Durvalumab

Phase 3 DeLLphi-305 Study Delivered Highly Significant and Clinically Meaningful Overall Survival Benefit Versus Durvalumab Alone Study Also Met Secondary Progression-Free Survival and Objective Response Rate Endpoints THOUSAND OAKS, Calif., Sept. 8, 2026 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced landmark results from the Phase 3 DeLLphi-305 study, which met its primary endpoint at a pre-specified interim analysis, demonstrating a statistically significant and clinically meaningful improvement in overall survival with IMDELLTRA® (tarlatamab-dlle) in combination with AstraZeneca's Imfinzi® (durvalumab) compared to durvalumab alone. This study tested IMDELLTRA as a first-line maintenance treatment for people with extensive stage small cell lung cancer (ES-SCLC) whose disease had not progressed following initial treatment with durvalumab, platinum-based chemotherapy and etoposide. The study also demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and objective response rate (ORR) among patients treated with IMDELLTRA in combination with durvalumab. Overall, the safety profile of IMDELLTRA in combination with durvalumab was consistent with the known safety profiles of the individual medicines. No new or unexpected safety signals were identified in DeLLphi-305. The study design included monitoring in a healthcare setting for 1 to 2 hours (6 to 8 hours in certain regions including Europe) following IMDELLTRA infusion on Cycle 1 Day 1 and Cycle 1 Day 8. "IMDELLTRA has already revolutionized the standard of survival for patients with extensive stage small cell lung cancer whose disease progressed on or after prior treatment. These landmark results from DeLLphi-305 suggest IMDELLTRA will further revolutionize the standard for survival earlier in the treatment journey and meaningfully shift the treatment paradigm for people facing this devastating disease," said Jay Bradner, M.D., executive vice president, Research and Development, Artificial Intelligence and Data at Amgen. "Despite clinical advances, extensive stage small cell lung cancer remains one of the most aggressive and difficult-to-treat cancers, and substantial improvements in survival are rare, underscoring the importance of these findings." This marks the first Phase 3 study including a Bispecific T-cell Engager (BiTE®) therapy to demonstrate an overall survival benefit in the first-line maintenance setting for ES-SCLC. "Given the aggressive nature of small cell lung cancer, many patients quickly relapse on current therapy and never reach second-line treatment. These patients do not have time to wait, making substantial progress in the first-line setting critically important," said Jacob Sands, MD, Associate Chief of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute. "In my career treating people with extensive stage small cell lung cancer, these are among the most compelling survival results I have seen, indicating the potential to reshape the natural history of small cell lung cancer. DeLLphi-305 represents an unprecedented milestone and suggests we may be entering a new era where meaningfully longer survival is possible for more patients." Following the U.S. Food and Drug Administration (FDA) approval of IMDELLTRA for adults with ES-SCLC whose disease has progressed on or after platinum-based chemotherapy, the robust global DeLLphi clinical trial program has continued to evaluate its potential across earlier stages of disease and lines of treatment, both as a monotherapy and in combination regimens. Building on the DeLLphi-303 trial, which showed very encouraging efficacy and tolerability results for IMDELLTRA in combination with anti-PD-L1 checkpoint inhibitors in the treatment of first-line ES-SCLC, DeLLphi-305 was designed to evaluate IMDELLTRA earlier in the course of disease, where more patients with SCLC may have the opportunity to benefit. SCLC is one of the most aggressive forms of lung cancer, accounting for approximately 13-15% of the more than 2.6 million lung cancer cases diagnosed worldwide each year.1-3 Despite advances in the treatment of ES-SCLC, outcomes remain poor, with a median survival of approximately one year from the start of first-line maintenance treatment and only about 40% of patients receiving second-line therapy.4-7 Amgen plans to present detailed data from DeLLphi-305 at an upcoming international medical congress and share it with regulatory authorities. About the Phase 3 DeLLphi-305 Study The DeLLphi-305 trial is sponsored by Amgen, with partial funding and durvalumab provided by AstraZeneca. It is a global Phase 3, randomized, open-label clinical trial evaluating the efficacy and safety of IMDELLTRA in combination with durvalumab compared to durvalumab alone as first-line maintenance treatment for patients with ES-SCLC who had not progressed following treatment with durvalumab, platinum-based chemotherapy and etoposide. Five hundred and sixty-three patients who completed initial treatment with durvalumab, platinum-based chemotherapy and etoposide were randomized 1:1 to receive either IMDELLTRA in combination with durvalumab or durvalumab alone until progression or unacceptable toxicity. Following IMDELLTRA infusion on Cycle 1 Day 1 and Cycle 1 Day 8, patients were monitored in a healthcare setting for 1 to 2 hours (6 to 8 hours in certain regions including Europe). The trial included patients with both treated and untreated asymptomatic brain metastases at baseline. The primary outcome measure of the trial is OS. Secondary endpoints include progression-free survival (PFS) and objective response rate (ORR).8 About Tarlatamab Clinical Trials Tarlatamab is being investigated in multiple studies including DeLLphi-303, a Phase 1b study investigating tarlatamab in combination with standard-of-care (SOC) therapies in first-line ES-SCLC; DeLLphi-304, a randomized Phase 3 study comparing tarlatamab monotherapy with SOC chemotherapy in second-line treatment of SCLC; DeLLphi-305, a randomized Phase 3 study comparing tarlatamab in combination with durvalumab vs. durvalumab alone as first-line maintenance treatment in ES-SCLC; DeLLphi-306, a randomized placebo-controlled Phase 3 study of tarlatamab following concurrent chemoradiotherapy in limited-stage SCLC; DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab in second-line or later ES-SCLC; DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens with tarlatamab in second-line ES-SCLC; DeLLphi-310, a Phase 1b study of tarlatamab in combination with YL201 with or without durvalumab in patients with ES-SCLC; DeLLphi-311, a Phase 1b study of tarlatamab in combination with etakafusp alfa (AB248), a novel CD8+ T-cell selective interleukin-2 (IL-2), in patients with ES-SCLC; DeLLphi-312, a randomized Phase 3 study evaluating tarlatamab in combination with durvalumab, carboplatin and etoposide as an induction and maintenance therapy in first-line treatment of ES-SCLC; DeLLphi-313, a Phase 1b study of tarlatamab in combination with zocilurtatug pelitecan, a DLL3 targeting antibody drug conjugate, with and without durvalumab in patients with ES-SCLC, and DeLLphi-315, a Phase 3 study of subcutaneous tarlatamab in patients with second-line ES-SCLC.9 For more information, please visit . About IMDELLTRA® (tarlatamab-dlle) IMDELLTRA is a first-in-class targeted immunotherapy engineered by Amgen researchers to bind to both DLL3 on tumor cells and CD3 on T cells, thereby activating T cells to kill DLL3-expressing SCLC cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell.10,11 DLL3 is a protein that is expressed on the surface of SCLC cells in ~85-96% of patients with SCLC, but is minimally expressed on healthy cells, making it an exciting target.12,13 U.S. INDICATION IMDELLTRA® (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA IMPORTANT SAFETY INFORMATION WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA ® . Initiate treatment with IMDELLTRA ® using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA ® until CRS resolves or permanently discontinue based on severity. Neurologic toxicity and immune effector cell-associated neurotoxicity syndrome (ICANS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA ® . Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA ® until ICANS resolves or permanently discontinue based on severity. WARNINGS AND PRECAUTIONS Cytokine Release Syndrome (CRS): IMDELLTRA® can cause CRS including life-threatening or fatal reactions. In the pooled safety population, CRS occurred in 57% (268/473) of patients who received IMDELLTRA®, including 39% Grade 1, 15% Grade 2, 1.7% Grade 3 and 0.2% Grade 4. Recurrent CRS occurred in 24% of IMDELLTRA®-treated patients including 20% Grade 1 and 3.4% Grade 2; one patient experienced recurrent Grade 3. Among the 268 patients who experienced CRS, 73% had CRS after the first dose, 60% had CRS after the second dose, and 15% had CRS following the third or later dose. Following the Cycle 1 Day 1, Day 8, Day 15 infusions, 24%, 8%, and 1% of patients experienced Grade ≥ 2 CRS, respectively. From Cycle 2 onwards, 1.5% of patients experienced Grade ≥ 2 CRS. Of the patients who experienced CRS, 31% received steroids and 10% required tocilizumab. The median time to onset of all grade CRS from most recent dose of IMDELLTRA® was 16 hours (range: start of infusion to 15 days). The median time to onset of Grade ≥ 2 CRS from most recent dose of IMDELLTRA® was 15 hours (range: start of infusion to 15 days). Clinical signs and symptoms of CRS included pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia, nausea, and vomiting. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC). Administer IMDELLTRA® following the recommended step-up dosing and administer concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA® infusions as described in Table 3 of the Prescribing Information (PI) to reduce the risk of CRS. Administer IMDELLTRA® in an appropriate healthcare facility equipped to monitor and manage CRS. Ensure patients are well hydrated prior to administration of IMDELLTRA®. Closely monitor patients for signs and symptoms of CRS during treatment with IMDELLTRA®. At the first sign of CRS, immediately discontinue IMDELLTRA® infusion, evaluate the patient for hospitalization and institute supportive care based on severity. Withhold or permanently discontinue IMDELLTRA® based on severity. Counsel patients and caregivers to seek medical attention should signs or symptoms of CRS occur. Neurologic Toxicity, Including ICANS: IMDELLTRA® can cause life-threatening or fatal neurologic toxicity, including ICANS. In the pooled safety population, neurologic toxicity occurred in 65% of patients who received IMDELLTRA®, with Grade 3 or higher events in 7% of patients including fatal events in 0.2%. The most frequent neurologic toxicities were dysgeusia (34%), headache (17%), peripheral neuropathy (9%), dizziness (9%), and insomnia (8%). The incidence of signs and symptoms consistent with ICANS was 10% in IMDELLTRA®-treated patients including events with the preferred terms: ICANS (4.7%), muscular weakness (3.2%), cognitive disorder (0.6%), aphasia (0.6%), depressed level of consciousness (0.4%), seizures (0.4%), encephalopathy (0.4%), and leukoencephalopathy (0.2%). There was one fatal reaction of ICANS. Recurrent ICANS occurred in 1.5% of patients. Of the patients who experienced ICANS, most experienced the event following Cycle 1 Day 1 (2.5%) and Cycle 1 Day 8 (3.6%). Following Day 1, Day 8, and Day 15 infusions, 1.3%, 1.3% and 0.4% of patients experienced Grade ≥ 2 ICANS, respectively. ICANS can occur several weeks following administration of IMDELLTRA®. The median time to onset of ICANS from the first dose of IMDELLTRA® was 16 days (range: 1 to 862 days). The median time to resolution of ICANS was 4 days (range: 1 to 40 days). The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia. Patients receiving IMDELLTRA® are at risk of neurologic adverse reactions and ICANS resulting in depressed level of consciousness. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until neurologic symptoms resolve. Closely monitor patients for signs and symptoms of neurologic toxicity and ICANS during treatment with IMDELLTRA®. At the first sign of ICANS, immediately discontinue the infusion, evaluate the patient and provide supportive therapy based on severity. Withhold IMDELLTRA® or permanently discontinue based on severity. Cytopenias: IMDELLTRA® can cause cytopenias including neutropenia, thrombocytopenia, and anemia. In the pooled safety population, based on laboratory data, decreased neutrophils occurred in 16% of patients, including 9% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased neutrophil count was 41 days (range: 2 to 306 days). Decreased platelets occurred in 30% including 2.2% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased platelets was 67 days (range: 3 to 420 days). Decreased hemoglobin occurred in 56% of patients, including 4.7% Grade 3 or 4. Febrile neutropenia was reported as an adverse event in 1.5% of patients treated with IMDELLTRA®. Monitor patients for signs and symptoms of cytopenias. Perform complete blood counts prior to treatment with all doses of IMDELLTRA®, up through Cycle 5 Day 15 and then prior to administration on Day 1 of each cycle starting with Cycle 6. Based on the severity of cytopenias, temporarily withhold, or permanently discontinue IMDELLTRA®. Infections: IMDELLTRA® can cause serious infections, including life-threatening and fatal infections. In the pooled safety population, infections, including opportunistic infections, occurred in 43% of patients who received IMDELLTRA®, including 14% Grade 3 or 4. The most frequent infections were pneumonia (11%), urinary tract infection (9%), COVID-19 (6%), upper respiratory tract infection (4.7%), respiratory tract infection (4%), candida infection (2.1%), oral candidiasis (2.1%), and nasopharyngitis (2.1%). Monitor patients for signs and symptoms of infection prior to and during treatment with IMDELLTRA® and treat as clinically indicated. Withhold or permanently discontinue IMDELLTRA® based on severity. Hepatotoxicity: IMDELLTRA® can cause hepatotoxicity. In the pooled safety population, based on laboratory data, elevated ALT occurred in 39% of patients who received IMDELLTRA®, including 2.5% with Grade 3 or 4 ALT. Elevated AST occurred in 43% of patients, including 3.2% Grade 3 or 4. Elevated bilirubin also occurred in 16% of patients, including 1.3% Grade 3 or 4. Liver enzyme elevation can occur with or without concurrent CRS. Monitor liver enzymes and bilirubin prior to treatment with IMDELLTRA®, and as clinically indicated. Withhold IMDELLTRA® or permanently discontinue based on severity. Hypersensitivity: IMDELLTRA® can cause severe hypersensitivity reactions. Clinical signs and symptoms of hypersensitivity may include, but are not limited to, rash and bronchospasm. Monitor patients for signs and symptoms of hypersensitivity during treatment with IMDELLTRA® and manage as clinically indicated. Withhold or consider permanent discontinuation of IMDELLTRA® based on severity. Embryo-Fetal Toxicity: Based on its mechanism of action, IMDELLTRA® may cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMDELLTRA® and for 2 months after the last dose. ADVERSE REACTIONS The pooled safety population reflects exposure to intravenous IMDELLTRA®, as a single agent, at the recommended dosage of IMDELLTRA® 1 mg on Cycle 1 Day 1 followed by 10 mg on Days 8 and 15, and then every 2 weeks until disease progression or intolerable toxicity in 473 patients with small cell lung cancer enrolled in three clinical trials: DeLLphi-300, DeLLphi-301 and DeLLphi-304. Among 473 patients who received IMDELLTRA®, 40% were exposed for 6 months or longer and 19% were exposed for greater than one year. The most common (≥ 20%) adverse reactions were CRS (57%), fatigue (48%), decreased appetite (38%), dysgeusia (34%), pyrexia (33%), constipation (31%), musculoskeletal pain (31%) and nausea (25%). The most common (≥ 5%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (43%), decreased sodium (12%), decreased total neutrophils (9%) and increased uric acid (6%). DOSAGE AND ADMINISTRATION: Important Dosing Information Administer IMDELLTRA® as an intravenous infusion over 1 hour. Administer IMDELLTRA® according to the step-up dose and schedule in the IMDELLTRA® PI (Table 1) to reduce the incidence and severity of CRS. Evaluate complete blood count, liver enzymes and bilirubin prior to administration of all doses of IMDELLTRA® up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA® on Day 1 of each cycle starting with Cycle 6. More frequent evaluation may be necessary if clinically indicated. For Cycle 1, administer recommended concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA® infusions to reduce the risk of CRS reactions as described in the PI (Table 3). IMDELLTRA® should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity including ICANS. Due to the risk of CRS and neurologic toxicity, including ICANS, monitor patients from the start of the IMDELLTRA® infusion for 22 to 24 hours following Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting. Recommend that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from the start of the infusion with IMDELLTRA® following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver. Inform both the patient and the caregiver on the signs and symptoms of CRS and ICANS prior to discharge. Ensure patients are well hydrated prior to administration of IMDELLTRA®. Please see IMDELLTRA® full Prescribing Information , including BOXED WARNINGS. About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines. More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, inflammatory conditions, rare diseases, heart disease and obesity and obesity-related conditions. Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. 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The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. CONTACT: Amgen, Thousand Oaks Brianna Wilkins, 513-284-9807 (media) Casey Capparelli, 805-447-1746 (investors) REFERENCES International Agency for Research on Cancer. Trachea, bronchus and lung fact sheet. Global Cancer Observatory: Cancer Today. Published 2024. Accessed September 2, 2026. . Oronsky B, Abrouk N, Caroen S, et al. A 2022 update on extensive stage small-cell lung cancer (SCLC). J Cancer. 2022;13(9):2945-2953. doi:10.7150/jca.75622. Sabari JK, Lok BH, Laird JH, Poirier JT, Rudin CM. Unravelling the biology of SCLC: implications for therapy. Nat Rev Clin Oncol. 2017;14(9):549-561. doi:10.1038/nrclinonc.2017.71. Cramer-van der Welle CM, Schramel FMNH, van Leeuwen AS, Groen HJM, van de Garde EMW; Santeon SCLC Study Group. Real-world treatment patterns and outcomes of patients with extensive disease small cell lung cancer. Eur J Cancer Care (Engl). 2020;29(5):e13250. doi:10.1111/ecc.13250. Shaw J, Pundole X, Balasubramanian A, et al. Recent treatment patterns and real-world survival following first-line anti-PD-L1 treatment for extensive-stage small cell lung cancer. Oncologist. 2024;29(12):1079-1089. doi:10.1093/oncolo/oyae234. Paz-Ares L, Borghaei H, Liu SV, et al. Efficacy and safety of first-line maintenance therapy with lurbinectedin plus atezolizumab in extensive-stage small-cell lung cancer (IMforte): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2025;405(10495):2129-2143. doi:10.1016/S0140-6736(25)01011-6. Reck M, Mok TSK, Mansfield A, et al. Brief report: exploratory analysis of maintenance therapy in patients with extensive-stage SCLC treated first line with atezolizumab plus carboplatin and etoposide. J Thorac Oncol. 2022;17(9):1122-1129. doi:10.1016/j.jtho.2022.05.016. ClinicalTrials.gov. DeLLphi-305 clinical trial listing. Accessed July 16, 2026. . ClinicalTrials.gov. Tarlatamab clinical trial listings. US National Library of Medicine. Accessed July 2026. . Giffin MJ, Cooke K, Lobenhofer EK, et al. AMG 757, a half-life extended, DLL3-targeted bispecific T-cell engager, shows high potency and sensitivity in preclinical models of small-cell lung cancer. Clin Cancer Res. 2021;27(5):1526-1537. doi:10.1158/1078-0432.CCR-20-2845. Baeuerle PA, Kufer P, Bargou R. BiTE: Teaching antibodies to engage T-cells for cancer therapy. Curr Opin Mol Ther. 2009;11(1):22-30. Ahn MJ, Cho BC, Felip E, et al. Tarlatamab for patients with previously treated small-cell lung cancer. N Engl J Med. 2023;389(22):2063-2075. doi:10.1056/NEJMoa2307980/ Rojo F, Corassa M, Mavroudis D, et al. International real-world study of DLL3 expression in patients with small cell lung cancer. Lung Cancer. 2020;147:237-243. doi:10.1016/j.lungcan.2020.07.026. 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Amgen is aiming to move its bispecific T-cell engager (BiTE) up earlier in the lung cancer treatment paradigm after Imdelltra (tarlatamab-dlle) succeeded as a maintenance therapy in a late-stage study.The pharma reported Tuesday that the DLL3/CD3–targeting BiTe met its primary endpoint of overall survival (OS) in the Phase III DeLLphi-305 study involving patients with extensive-stage small-cell lung cancer (ES-SCLC) whose disease had not progressed following initial treatment.The trial enrolled 563 patients with ES-SCLC who had already received AstraZeneca's Imfinzi (durvalumab), platinum-based chemotherapy and etoposide. Participants were randomised to receive either Imdelltra plus Imfinzi, or Imfinzi alone, until progression or unacceptable toxicity. The duo achieved a statistically significant and clinically meaningful improvement in OS compared with Imfinzi monotherapy, making Imdelltra the first BiTE to demonstrate an OS benefit as a first-line maintenance treatment for ES-SCLC in a Phase III trial, Amgen said. The combination also met its key secondary endpoints of progression-free survival and objective response rate (ORR)."These landmark results from DeLLphi-305 suggest Imdelltra will further revolutionise the standard for survival earlier in the treatment journey and meaningfully shift the treatment paradigm for people facing this devastating disease," said Jay Bradner, EVP of R&D, AI and data at Amgen.In regards to safety, Amgen reported that Imdelltra's profile was consistent with past studies, with no new or unexpected signals. Label expansion plansImdelltra's win in the maintenance setting comes about two years after the FDA granted the BiTe an accelerated approval to treat patients with ES-SCLC with disease progression on or after platinum-based chemotherapy.The clearance was based on results of the 99-patient Phase II DeLLphi-301 study, which showed Imdelltra led to an ORR of 40% and a median OS of over 13 months (see – KOL Views Q&A: Leading oncologist remains optimistic about targeting DLL3 in SCLC)According to Amgen, the DeLLphi-305 trial was designed to evaluate Imdelltra "earlier in the course of disease, where more patients with SCLC may have the opportunity to benefit." The drugmaker plans to share the study's findings with global regulators, and will present detailed data at an upcoming medical meeting.  Outside of ES-SCLC, Amgen is also studying Imdelltra in the Phase Ib STREAM-SCLC study involving patients with limited-stage SCLC. The trial was selected by the FDA in April to pilot a new model for real-time clinical trials.