Combining Tarlatamab and YL201 for treating extensive stage small cell lung cancer

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With YL201 With or Without Anti-PD-L1 in Subjects With Extensive Stage Small Cell Lung Cancer

This study is testing a new combination of two treatments, tarlatamab and YL201, to see if they can help people with advanced small cell lung cancer feel better and improve their health.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Amgen (industry)
• Drugs / interventions: chemotherapy, tarlatamab
• Locations: 2 sites (Saint Louis, Missouri and 1 other locations)
• Trial ID: NCT06898957 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of tarlatamab in combination with YL201, with or without the addition of anti-PD-L1 therapies, in patients with extensive stage small cell lung cancer (SCLC). Participants must have confirmed ES-SCLC that has either progressed after prior treatments or has not received systemic treatment beyond initial chemotherapy. The study aims to assess the effectiveness of this combination therapy in managing the disease and improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed extensive stage small cell lung cancer that has progressed after at least one line of platinum-based therapy.

Not a fit: Patients with prior exposure to specific targeted therapies or symptomatic central nervous system metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with extensive stage small cell lung cancer.

How similar studies have performed: Other studies have shown promise with similar combination therapies in small cell lung cancer, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Participants ≥ 18 years of age (or legal adult age within country) at time of signing informed consent.
* Participants with histologically or cytologically confirmed ES-SCLC.
* For Parts 1 and 2, participant must have ES-SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.
* For Part 3, participants must have ES-SCLC and no prior systemic treatment for ES SCLC other than 1 cycle of platinum-based chemotherapy, etoposide, and PD-(L)1 inhibitor in the first-line setting.
* At least 1 measurable lesion as defined by RECIST 1.1.
* Participants must have adequate organ function (cardiac, pulmonary, kidney, bone marrow, and liver).

Exclusion Criteria:

* Prior delta-like ligand 3 (DLL3) or B7 homolog 3 (B7-H3) targeted therapy.
* Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.
* Symptomatic central nervous system (CNS) metastases. Note: Participants with asymptomatic brain metastases are eligible as defined in the protocol.
* History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
* Baseline requirement of supplemental oxygen.

Where this trial is running

Saint Louis, Missouri and 1 other locations

• Washington University — Saint Louis, Missouri, United States (RECRUITING)
• Shandong Cancer Hospital — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Amgen Call Center

Conditions: Small Cell Lung Cancer, Small cell lung cancer, SCLC, Tarlatamab, YL201, Anti-PD-L1, Atezolizumab, Durvalumab