Study of Novel Treatment Combinations in Patients With Lung Cancer

Conditions

• Advanced or Metastatic Non-Small-Cell Lung Cancer
• Lung Cancer
• Resectable Non-Small-Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zimberelimab (ZIM) — DRUG
  Administered intravenously
• Domvanalimab (DOM) — DRUG
  Administered intravenously
• Sacituzumab govitecan-hziy (SG) — DRUG
  Administered intravenously
• Etrumadenant (ETRUMA) — DRUG
  Administered orally
• Carboplatin — DRUG
  Administered intravenously
• Cisplatin — DRUG
  Administered intravenously
• Pemetrexed — DRUG
  Administered intravenously
• Paclitaxel — DRUG
  Administered intravenously
• Nab-paclitaxel — DRUG
  Administered intravenously
• Docetaxel — DRUG
  Administered intravenously
• Nivolumab — DRUG
  Administered intravenously

Study Details

The goal of this platform clinical trial is to test how well novel treatment combinations work in participants with lung cancer. Substudy-01 will compare the different novel combinations versus standard of care in participants with metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC) who have not been treated before. Substudy-02 will compare the different novel combination versus standard of care in participants with cancer that has progressed after receiving previous treatment for metastatic NSCLC. Substudy-03 will compare the different novel combinations versus standard of care in participants with resectable stage II-III NSCLC. The primary objectives of this study are: Substudy-01 and Substudy-02: To evaluate the objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Substudy-03: To evaluate the efficacy of treatment combinations based on complete pathological response (pCR) rate.

Key Dates

Start date

Mar 16, 2023

Status verified

May 2026

Primary completion

Sep 30, 2029

Completion

Sep 30, 2029

Study Design

Enrollment

192 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM)
  Participants will receive ZIM, SG and DOM until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met.
• Experimental: Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA)
  Participants will receive ZIM, DOM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
• Experimental: Substudy 01: ZIM + ETRUMA
  Participants will receive ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
• Experimental: Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG)
  Participants will receive ZIM and SG until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met.
• Active Comparator: Substudy 01: ZIM + Platinum Based Chemotherapy
  Expansion Stage Only: Participants will receive ZIM plus any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be cisplatin or carboplatin and pemetrexed (non-squamous histology) or carboplatin, paclitaxel and nabpaclitaxel (squamous histology).
• Experimental: Substudy 02: SG + ZIM + ETRUMA
  Participants will receive SG, ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
• Active Comparator: Substudy 02: Either Docetaxel or SG (Monotherapy Only)
  Participants will receive either Docetaxel or SG until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
• Experimental: Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy
  Participants will receive ZIM plus DOM and any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology).
• Experimental: Substudy 03 - ZIM + Platinum-based Chemotherapy
  Participants will receive ZIM plus any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology).
• Active Comparator: Substudy 03: Nivolumab + Platinum-based Chemotherapy
  Participants will receive nivolumab plus any one of the chemotherapy (choice of chemotherapy is dependent on histology). Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology).

Primary Outcome Measure

Substudies 01 and 02: Objective Response Rate (ORR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Up to 5 years ]

Locations (11)

Find similar trials in Tucson, AZ

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