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).
Patient must have histologically or cytologically confirmed Small Cell Lung Cancer (SCLC).
SCLC must be diagnosed as Limited-Stage-SCLC (LS-SCLC) (Stage I-III, disease can be encompassed within a radical radiation portal per investigator assessment) and treated with 3 to 4 cycles of chemotherapy and radiation therapy. Three cycles of chemotherapy will be acceptable if the planned radiation therapy course is completed concurrently with chemotherapy.
Patient must not be eligible for surgical resection or have had prior surgical resection for the current diagnosis of LS-SCLC.
Small cell carcinoma may not be transformed from previous diagnosis of non-small cell lung cancer (e.g., Epidermal Growth Factor Receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) with SCLC transformation). Mixed histology (aka combined small cell) histology tumors are permitted if the majority component is small cell histology.
None
Parallel
Tarlatamab
DrugTarlatamab 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
DrugDurvalumab 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.
This phase III study has dual primary endpoints of progression-free survival (PFS) and overall survival (OS).
The dual primary endpoints are PFS by Blinded Independent Central Review (BICR) and OS. OS is defined as time from randomization until death due to any cause.
This phase III study has dual primary endpoints of progression-free survival (PFS) and overall survival (OS).
The dual primary endpoints are PFS by Blinded Independent Central Review (BICR) and OS. PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first, in the absence of subsequent anticancer therapy. For participants with post-baseline imaging assessments, PFS will be censored at the last evaluable post-baseline tumor assessment prior to subsequent anticancer therapy or the earlier of the following, where applicable: (a) the last evaluable post-baseline tumor assessment prior to or on subsequent anticancer therapy, or (b) the last post-baseline assessment that precedes two or more consecutive missing/not evaluable assessments followed by disease progression or death. For participants with no post-baseline imaging assessments, PFS will be censored at the date of randomization.
Secondary endpoints include safety/tolerability.
Toxicity will be determined using the CTCAE V6.0. Toxicity will be assessed by summaries by CTCAE grade. Participants will be followed for adverse events for 90 (+5) days after their last dose of study medication. However, if a participant experiences an adverse event \>90 (+5) days after their last dose of study medication that is felt to be, in the opinion of the investigator, possibly, probably or definitely related to study therapy, the adverse event should be reported.
Secondary endpoints include investigator-assessed PFS.
Secondary objectives include to evaluate the difference in investigator-assessed PFS per RECIST 1.1 with tarlatamab + durvalumab as compared to durvalumab alone.
Secondary endpoints 3 and 5-year PFS rate
3 and 5-year PFS is defined as the Kaplan-Meier-estimated probabilities of being alive and progression-free at 3 years and 5 years.
Secondary endpoints include 3 and 5-year OS rate.
3 and 5-year OS is defined as the Kaplan-Meier-estimated probabilities of being alive at 3 years and 5 years.
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PrECOG, LLC.
Lead sponsor
Amgen
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
