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NCT Number: NCT06898957

Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC)

The primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU de Quebec Hopital de l Enfant Jesus, Québec, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, subjects must have ES-SCLC that has progressed or recurred following at least 1 prior line of platinum-based anti-cancer therapy received either for LS-SCLC or ES-SCLC.
  • For Part 3, subjects must have ES-SCLC and no prior systemic treatment for ES SCLC other than 1 cycle of platinum-based chemotherapy, and etoposide, and with or without 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.

Treatment and study plan

YL201

Drug

YL201 will be administered as an IV infusion.

Tarlatamab

Drug

Tarlatamab will be administered as an IV infusion.

Durvalumab

Drug

Durvalumab will be administered as an IV infusion.

Primary outcomes

  1. Number of Participants Experiencing Dose-limiting toxicities (DLTs)

    Time frame: Up to Day 21

  2. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to 3.5 Years

Secondary outcomes

  1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Time frame: Up to 3.5 Years

  2. Duration of Response (DOR) per RECIST 1.1

    Time frame: Up to 3.5 Years

  3. Time to Response (TTR) per RECIST 1.1

    Time frame: Up to 3.5 Years

  4. Disease Control Rate (DCR) per RECIST 1.1

    Time frame: Up to 3.5 Years

  5. Progression-free Survival (PFS) per RECIST 1.1

    Time frame: Up to 3.5 Years

  6. Time to Progression (TTP) per RECIST 1.1

    Time frame: Up to 3.5 Years

  7. Time to Subsequent Therapy

    Time frame: Up to 3.5 Years

  8. Overall Survival (OS)

    Time frame: Up to 3.5 Years

  9. Maximum Serum Concentration (Cmax) of Tarlatamab

    Time frame: Up to Week 36

  10. Minimum Serum Concentration (Cmin) of Tarlatamab

    Time frame: Up to Week 36

  11. Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for Tarlatamab

    Time frame: Up to Week 36

  12. Half-life (t1/2) of Tarlatamab

    Time frame: Up to Week 36

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

  • MediLink

Registry information

Official study title

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

Acronym: (DeLLphi-310)

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Mar 27, 2025
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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