Tarlatamab plus AB248 for extensive-stage small cell lung cancer (DeLLphi-311)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, open-label dose-exploration and expansion trial combines the bispecific T-cell engager tarlatamab with AB248 in adults with extensive-stage small cell lung cancer that progressed after at least one prior systemic therapy. During dose exploration the study will escalate AB248 to determine the recommended dose for expansion and the maximum tolerated combination dose when given with tarlatamab, followed by dose expansion cohorts to further characterize safety and preliminary activity. Key requirements include measurable disease per RECIST 1.1, adequate organ function, and submission of a fresh tumor biopsy when feasible. The trial is sponsored by Amgen with collaborating sites at major US cancer centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participant has provided informed consent before initiation of any study-specific activities/procedures.
2. Participants ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
3. Participants with histologically or cytologically confirmed ES-SCLC that has progressed or recurred following at least 1 line of anti-cancer therapy for ES-SCLC.
4. Participants must have at least 1 measurable lesion as defined by RECIST 1.1 within 21-day screening period, not previously irradiated.
5. Participants must have adequate organ function (hematological, coagulation, cardiac, pulmonary, kidney, and liver).
6. Participants must submit a fresh tumor biopsy at screening unless a new biopsy cannot be performed safely or is infeasible. Participants who cannot provide fresh tissue may provide archival tissue that was collected after last anticancer therapy.

Exclusion Criteria:

1. Symptomatic central nervous system (CNS) metastases.
2. Participants with brain metastases may be eligible if criteria defined in the protocol are met.
3. Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy (including tarlatamab).
4. Prior interleukin (IL)-2, IL-7 or IL-15 targeted therapy.
5. Baseline (at rest) requirement of supplemental oxygen.

Where it's running

• University of Southern California, Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Norton Cancer Institute - Downtown
  Louisville, Kentucky, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Siteman Cancer Center
  St Louis, Missouri, United States Recruiting

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tarlatamab treatment for extensive stage small cell lung cancer

  This study is testing a new treatment called tarlatamab for people with extensive stage small cell lung cancer who haven't had success with previous chemotherapy to see if it helps them feel better.

  Recruiting at 31 sites Phase 1 Amgen · Los Angeles, California and 30 other locations · NCT06598306

• Tarlatamab in strong-performance-status small-cell lung cancer

  This trial tests whether tarlatamab can help people with extensive-stage small-cell lung cancer and poor health (ECOG 2) who have already had prior treatment.

  Recruiting at 8 sites Phase 2 AIO-Studien-gGmbH · Berlin and 7 other locations · NCT07803848

• QLC5508 plus QL2107 vs tislelizumab plus platinum chemotherapy as first treatment for extensive-stage small cell lung cancer

  This phase 3 trial tests whether QLC5508 with QL2107 works better than tislelizumab with platinum chemotherapy for adults with untreated extensive-stage small cell lung cancer.

  Recruiting Phase 3 Qilu Pharmaceutical Co., Ltd. · Shanghai · NCT07802821

• Tarlatamab given under the skin vs by IV in extensive-stage small cell lung cancer after platinum therapy

  This trial tests whether subcutaneous tarlatamab works as well as the IV form for people with extensive-stage small cell lung cancer after platinum chemotherapy.

  Recruiting at 9 sites Phase 3 Amgen · Orlando, Florida and 8 other locations · NCT07778316

• BL-M14D1 with Atezolizumab for extensive-stage small cell lung cancer

  This phase 2 trial tests whether adding BL-M14D1 to atezolizumab helps people with extensive-stage small cell lung cancer live longer or well enough to continue treatment.

  Recruiting Phase 2 Biokin (Shanghai) Biopharmaceutical Co., Ltd. · Shanghai, Shanghai Municipality · NCT07654400

• Tislelizumab use in European patients with NSCLC or ES-SCLC in routine care

  This study looks at how tislelizumab is used in real-world European patients with advanced NSCLC or extensive-stage SCLC and what outcomes are seen in everyday clinical practice.

  Recruiting at 6 sites BeOne Medicines · Córdoba and 5 other locations · NCT07652736

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.