Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)

Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Study ID
NCT06937905
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard of Care Chemotherapy — DRUG
    Study treatment in the arm A is left to the investigator appreciations. This may include immune checkpoint inhibitors, docetaxel, topotecan for primary lung tumors, and FOLFOX, FOLFIRI or alkylating-based chemotherapy in primary digestive tumors.
  • Tarlatamab — DRUG
    Tarlatamab 10 mg every 2 weeks

Study Details

Based on the efficacy of tarlatamab in patients with small-cell lung cancer, we aim to assess the efficacy of tarlatamab in patients with Advanced, pulmonary (large-cell only) or gastroenteropancreatic neuroendocrine carcinoma.

Key Dates

Start date
Feb 6, 2026
Status verified
Feb 2026
Primary completion
Feb 1, 2029
Completion
Aug 1, 2030

Study Design

Enrollment
129 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A : Standard of care chemotherapy
    Study treatment in the arm A is left to the investigator appreciations. This may include immune checkpoint inhibitors, docetaxel, topotecan for primary lung tumors, and FOLFOX, FOLFIRI or alkylating-based chemotherapy in primary digestive tumors.
  • Experimental: Arm B : Tarlatamab
    Tarlatamab 10 mg every 2 weeks

Primary Outcome Measure

Overall survival (OS) in patients who received at least one dose of treatment. [ Time Frame: About 4 years ]

Central Contacts

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