Tarlatamab and Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer

Sponsor
PrECOG, LLC.
Study ID
NCT07637513
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Limited Stage Small-Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Tarlatamab — DRUG
    Tarlatamab Intravenous (IV): Cycle 1 Step Dose: Day 1- 1 mg; Day 8- 10 mg; Day 15- 10 mg of a 28-day cycle, then Cycle 2 and Subsequent Cycles: Day 1- 10 mg and Day 15- 10 mg every 28-day cycle up to 12 months from cycle 1 day 1 unless other treatment discontinuation or rechallenge criteria are met.
  • Durvalumab — DRUG
    Durvalumab 1500 mg IV: Every 4 weeks until disease progression, unacceptable toxicity, or a maximum of 24 months from cycle 1 day 1, unless other treatment discontinuation criteria are met.

Study Details

Eligible participants with limited stage-small cell lung cancer (LS-SCLC) will be enrolled after completion of chemotherapy and radiation. Participants will be randomized to either tarlatamab in combination with durvalumab or durvalumab alone as consolidation therapy. Treatment will continue until disease progression, unacceptable side effects or withdrawal of consent. Tarlatamab is a targeted cancer treatment. It works by acting as a matchmaker between the immune system's T-cells and the cancer cells, forcing them to come together so the T-cells can attack the cancer. Image testing will be done standardly during treatment. These tests show whether the cancer has progressed and if further treatment may be needed. The purpose of this trial is to evaluate how well the treatment works (how long before your cancer comes back and how long you live).

Key Dates

Start date
Jan 31, 2027
Status verified
Jun 2026
Primary completion
Nov 30, 2037
Completion
Jun 30, 2038

Study Design

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

Arms

  • Experimental: Arm A: Tarlatamab in Combination with Durvalumab
    Tarlatamab in combination with durvalumab. 1 cycle = 28 days.
  • Active Comparator: Arm B: Durvalumab
    Durvalumab only. 1 cycle = 28 days.

Primary Outcome Measure

This phase III study has dual primary endpoints of progression-free survival (PFS) and overall survival (OS). [ Time Frame: From randomization until death due to any cause, assessed up to 131 months. ]

Central Contacts

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