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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPrECOG, LLC.

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Tarlatamab
  • Durvalumab

Treatment groups

430 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

PrECOG, LLC.

Lead sponsor

Amgen

Collaborator