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Tarlatamab as maintenance treatment after chemo-radiotherapy for limited-stage small-cell lung cancer.

A Phase II Clinical Trial of Tarlatamab as Maintenance Treatment After Sequential Chemo-radiotherapy for Limited Stage SCLC Patients Not Eligible for Concurrent Chemo-radiotherapy

Phase 2 Interventional Fundación GECP · NCT07242547

This trial will test whether giving tarlatamab after chemo-radiotherapy helps people with limited-stage small-cell lung cancer stay progression-free longer.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment37 (estimated)
Ages18 Years and up
SexAll
SponsorFundación GECP Academic / other
Drugs / interventionschemotherapy, radiation, Tarlatamab
Locations20 sites (Albacete, Albacete and 19 other locations)
Trial IDNCT07242547 on ClinicalTrials.gov

What this trial studies

MERLIN is an open-label, phase II, multi-center trial enrolling 37 patients with limited-stage small-cell lung cancer who are not eligible for concurrent chemo‑radiotherapy. Eligible patients who complete sequential chemo‑radiotherapy (or chemotherapy alone) without disease progression will receive intravenous tarlatamab as maintenance therapy until progression, unacceptable toxicity, withdrawal, or death. The primary endpoint is progression-free survival (time from enrollment to RECIST v1.1 progression or death), with tumor response followed even if treatment is stopped. Enrollment is expected to take about 2 years with total study duration, including follow-up, of approximately 5 years.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed limited-stage small-cell lung cancer who completed sequential chemo‑radiotherapy or chemotherapy alone without progression, have ECOG 0–2, resolved treatment toxicities (≤ grade 1), and life expectancy ≥3 months are ideal candidates.

Not a fit: Patients with disease progression after chemo‑radiotherapy, mixed histology tumors, unresolved high-grade toxicities, significant ECG abnormalities, or ECOG performance status >2 are unlikely to be eligible or to benefit from this maintenance approach.

Why it matters

Potential benefit: If effective, tarlatamab maintenance could prolong the time patients live without their cancer getting worse and delay the need for further therapy.

How similar studies have performed: Early-phase trials of tarlatamab in relapsed small-cell lung cancer have shown promising responses, but using tarlatamab as maintenance after chemo‑radiotherapy is a novel approach without established proof of benefit.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Histologically or cytologically documented new diagnosis of LS-SCLC by histology or cytology from brushing, washing, or needle aspiration. Mixed tumors are not eligible.
* Patients who:

  1. were treated with sequential chemo-radiotherapy
  2. were treated only with chemotherapy
* Have at least one lesion that meets criteria for being measurable or non-measurable, as defined by RECIST 1.1.
* Has completed chemo-radiation or chemotherapy alone without progression of disease per RECIST v1.1
* Be male or female ≥18 years of age inclusive, on the day of signing informed consent.
* Have a life expectancy of at least 3 months from the study start.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days prior to the first dose of study intervention.
* Toxicities attributed to chemo-radiotherapy treatment have to be resolved to grade ≤1, unless otherwise specified.
* No clinically significant electrocardiogram (ECG) findings
* Correct pulmonary function without oxygen supplementation
* Have voluntarily agreed to participate by giving written consent for the study prior to any specific protocol procedures.
* Have adequate organ function (hematological and biochemistry parameters).

Exclusion Criteria:

* Patients expected to require any other form of radiation therapy for LS-SCLC as concurrent radiotherapy.
* Extensive-stage SCLC (ES-SCLC) or any previous diagnosis of transformed non-small cell lung cancer. Mixed tumors (SCLC-NSCLC) are not eligible.
* Has known history of, or active, neurologic paraneoplastic syndrome of autoimmune nature.
* Has had major surgery within 4 weeks prior to first dose of study interventions.
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
* Has known history of a second malignancy other than SCLC, unless potentially curative treatment has been completed with no evidence of malignancy for at least 3 years since the initiation of that therapy.
* Uncontrolled intercurrent active infection at the time of enrollment requiring systemic therapy.
* Evidence of interstitial lung disease or active, non-infectious pneumonitis.
* History of solid organ transplantation.
* Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \>class II) within 6 months prior to first dose of study treatment.
* Has a known history of Human Immunodeficiency Virus (HIV) infection.
* Has a known history of Hepatitis B or known active Hepatitis C virus infection.
* Has a known history of active tuberculosis.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Has serious nonhealing wound, ulcer, or bone fracture within 28 days before first dose of study intervention.
* Female subjects of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of study treatment.
* Female subjects who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of study treatment.
* Female subjects planning to become pregnant or donate eggs while on study through 60 days after the last dose of study treatment.
* Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test.
* Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence or use contraception during treatment and for an additional 60 days after the last dose of study treatment.
* Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of study treatment.
* Subject has known sensitivity to any of the products or components to be administered during dosing.

Where this trial is running

Albacete, Albacete and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Limited-stage Small-cell Lung CancerCarcinoma, Small Cell LungRespiratory Tract NeoplasmsThoracic NeoplasmsNon small cell lung cancerTarlatamabMaintenance treatmentAntineoplastic Agents
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.