- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Trial completion date, Trial primary completion date: DeLLphi-301: A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Sep 19, 2024 P2, N=222, Active, not recruiting, Bispecific T cell engagers may offer a novel treatment approach for large cell neuroendocrine carcinoma of the lung. Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2024 --> Oct 2025
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Review, Journal: Tarlatamab: First Approval. (Pubmed Central) - Aug 23, 2024 Tarlatamab is under regulatory review in Brazil, Canada, Israel and the UK, and clinical studies are underway in multiple countries. This article summarizes the milestones in the development of tarlatamab leading to this first approval for ES-SCLC with disease progression on or after platinum-based chemotherapy.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
DeLLphi-306 Trial: A Phase 3 Study of Tarlatamab after Concurrent Chemoradiotherapy in Limited-Stage Small Cell Lung Cancer (Exhibit Hall) - Aug 4, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2696; P3 Other secondary endpoints include investigator-assessed PFS, investigator and BICR-assessed objective response rate, disease control rate, duration of response, time to progression (all per RECIST 1.1), incidence of treatment-emergent and treatment-related adverse events, serum concentrations of tarlatamab, and incidence of anti-tarlatamab antibody formation. This trial is actively recruiting patients.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
DeLLphi-306 Trial: A Phase 3 Study of Tarlatamab after Concurrent Chemoradiotherapy in Limited-Stage Small Cell Lung Cancer (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1434; P3 Other secondary endpoints include investigator-assessed PFS, investigator and BICR-assessed objective response rate, disease control rate, duration of response, time to progression (all per RECIST 1.1), incidence of treatment-emergent and treatment-related adverse events, serum concentrations of tarlatamab, and incidence of anti-tarlatamab antibody formation. This trial is actively recruiting patients.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen, Imfinzi (durvalumab) / AstraZeneca
Tarlatamab Plus Durvalumab as First-Line Maintenance in Extensive-Stage Small Cell Lung Cancer: DeLLphi-305 Phase 3 Trial (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1430; P3 Key exclusion criteria are prior DLL3 pathway-selective inhibitor therapy, active or documented autoimmune or inflammatory disorders per protocol, known human immunodeficiency virus, hepatitis C and/or hepatitis B infections with exceptions according to the protocol, and a history of severe/life-threatening events from immune-mediated therapy. The primary endpoint is OS and key secondary endpoints include progression-free survival, objective response rate, disease control rate, duration of response, safety, and quality of life assessments.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen, Imfinzi (durvalumab) / AstraZeneca
Tarlatamab Plus Durvalumab as First-Line Maintenance in Extensive-Stage Small Cell Lung Cancer: DeLLphi-305 Phase 3 Trial (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1184; P3 Key exclusion criteria are prior DLL3 pathway-selective inhibitor therapy, active or documented autoimmune or inflammatory disorders per protocol, known human immunodeficiency virus, hepatitis C and/or hepatitis B infections with exceptions according to the protocol, and a history of severe/life-threatening events from immune-mediated therapy. The primary endpoint is OS and key secondary endpoints include progression-free survival, objective response rate, disease control rate, duration of response, safety, and quality of life assessments.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Journal: Tarlatamab (Imdelltra) for small cell lung cancer. (Pubmed Central) - Jul 9, 2024 The longer follow-up at time of presentation will provide clearer insight on response durability and long-term survival. No abstract available
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
DLL3 Expression In Early () - Jun 23, 2024 - Abstract #LUNGSPORE2024LUNG_SPORE_86; A trend for improved survival in patients with no DLL3 expression was observed. Future studies on DLL3 might improve SCLC treatment SCLC.
- |||||||||| tarlatamab (AMG 757) / Amgen, Rova-T (rovalpituzumab tesirine) / AbbVie
Journal: DLL3-guided therapies in small-cell lung cancer: from antibody-drug conjugate to precision immunotherapy and radioimmunotherapy. (Pubmed Central) - May 11, 2024 Although rovalpituzumab tesirine (Rova-T) showed promise in a phase II study, it failed to produce favorable results in subsequent phase III trials, leading to the cessation of its development...Tarlatamab, for instance, demonstrated enhanced response rates and progression-free survival compared to the standard of care in a phase II trial; its biologics license application (BLA) is currently under US Food and Drug Administration (FDA) review...DLL3-targeted therapies hold substantial potential for SCLC management. Future clinical trials will be crucial for comparing treatment outcomes among various approaches and exploring combination therapies to improve patient survival outcomes.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
DeLLphi-301: Tarlatamab phase 2 trial in small cell lung cancer (SCLC) (S406) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3262; P2 Trial primary completion date: Dec 2025 --> Jan 2027 Tarlatamab showed promising efficacy and a favorable benefit-risk profile in patients with previously treated SCLC and stable brain metastases.
- |||||||||| tarlatamab (AMG 757) / Amgen
Impact of patient specific factors on exposures of tarlatamab, a half-life extended DLL3-directed bispecific T-cell engager in patients with advanced small cell lung cancer (Section 24) - Mar 5, 2024 - Abstract #AACR2024AACR_9373; P1, P2 Not yet recruiting --> Recruiting Overall, based on these analyses, no dose adjustment for tarlatamab is required based on age, sex, bodyweight, ethnicity, estimates of renal and hepatic function, prior lines of therapy, baseline disease status or emergence of ADA.
- |||||||||| Imdelltra (tarlatamab-dlle) / Amgen
Trial completion date, Trial primary completion date: DeLLphi-301: A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Mar 2, 2024 P2, N=222, Active, not recruiting, None of the evaluated patient-specific covariates resulted in clinically meaningful changes in efficacy or safety, and therefore do not warrant a dose adjustment. Trial completion date: Feb 2025 --> Oct 2025 | Trial primary completion date: Feb 2024 --> Oct 2024
- |||||||||| tarlatamab (AMG 757) / Amgen
Tarlatamab after chemoradiotherapy in limited-stage small cell lung cancer (LS-SCLC): DeLLphi-306 (NCT06117774) (Congress Hall Foyer) - Feb 6, 2024 - Abstract #ELCC2024ELCC_547; P3 Primary endpoint is progression-free survival (PFS) per blinded independent central review (RECIST 1.1) with OS as a key secondary endpoint. Additional secondary endpoints include investigator-assessed PFS, objective response, disease control, duration of response, time to progression, pharmacokinetics, tarlatamab immunogenicity, and safety/tolerability.
- |||||||||| tarlatamab (AMG 757) / Amgen
Journal: Tarlatamab Shows Promise in SCLC. (Pubmed Central) - Dec 17, 2023 Tarlatamab, an investigational bispecific T-cell engager molecule that targets the cell surface protein delta-like ligand 3, has shown promising activity in patients with small cell lung cancer whose disease had progressed after receiving another therapy. Questions remain over whether clinicians and patients would use the drug given its challenging administration.
- |||||||||| Imdelltra (tarlatamab) / Amgen, zeluvalimab (AMG 404) / Amgen
Trial completion date, Combination therapy: AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - Oct 11, 2023 P1b, N=23, Active, not recruiting, Trial completion date: Nov 2025 --> Jan 2027 | Trial primary completion date: Nov 2024 --> Dec 2025 Trial completion date: Jan 2026 --> Jan 2025
- |||||||||| Imdelltra (tarlatamab) / Amgen
Trial completion date: DeLLpro-300: A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer (clinicaltrials.gov) - Sep 22, 2023 P1b, N=41, Active, not recruiting, These data support the continued clinical evaluation of tarlatamab in patients with SCLC, including in combination with chemo-immune therapy in the first-line setting. Trial completion date: May 2025 --> Aug 2025
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