Study of Novel Treatment Combinations in Patients With Lung Cancer (VELOCITY-Lung)

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Gilead Sciences

Status and phase

Enrolling
Phase 2

Conditions

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

Treatments

Drug: Nab-paclitaxel
Drug: Etrumadenant (ETRUMA)
Drug: Paclitaxel
Drug: Pemetrexed
Drug: Cisplatin
Drug: Sacituzumab govitecan-hziy (SG)
Drug: Docetaxel
Drug: Zimberelimab (ZIM)
Drug: Nivolumab
Drug: Domvanalimab (DOM)
Drug: Carboplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT05633667
MOH_2022-12-13_012231 (Registry Identifier)
GS-US-624-6376

Details and patient eligibility

About

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 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.

Enrollment

397 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria: All Substudies: * Histologically or cytologically documented non-small-cell lung cancer (NSCLC). * No known actionable genomic alterations for which targeted therapies are available. * Eastern cooperative oncology group (ECOG) performance status score of 0 or 1. * Measurable disease per response evaluation criteria in solid tumors. * Adequate hematologic and end-organ function. * Individuals of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception. Substudy 01: All Experimental arms * Stage IV NSCLC. * For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative. * PD-L1 status by central confirmation. * No prior systemic treatment for metastatic NSCLC. Substudy 02: All Experimental arms * Stage IV NSCLC. * In individuals with nonsquamous histology and actionable EGFR, ALK, or other known genomic alterations must have received treatment with at least 1 targeted therapy to the appropriate genomic alteration. Substudy 03: All Experimental arms * Previously untreated individuals with resectable (Stage II, IIIA, IIIB (T\[3-4\]N2) NSCLC (per American Joint Committee on Cancer (AJCC) Edition 8). * Planned surgery must comprise of lobectomy, sleeve lobectomy, or bi-lobectomy. * PD-L1 status by central confirmation. * For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative. Key Exclusion Criteria: All Substudies: * Mixed small-cell lung cancer and NSCLC histology. * Active second malignancy. * Active autoimmune disease. * History of or current non-infectious pneumonitis/interstitial lung disease. * Active serious infection within 4 weeks prior to study treatment. Substudy 01 and 02 * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Received previous anticancer therapy within 4 weeks prior to enrollment. Substudy 03: All Experimental arms * NSCLC previously treated with systemic therapy or radiotherapy. * Received prior treatment with any anti-PD-(L)-1 or other immune checkpoint inhibitors (CPIs). Note: Other protocol defined inclusion/exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

397 participants in 9 patient groups

Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM)
Experimental group
Description:
Participants will receive ZIM, SG and DOM until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met.
Treatment:
Drug: Domvanalimab (DOM)
Drug: Zimberelimab (ZIM)
Drug: Sacituzumab govitecan-hziy (SG)
Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA)
Experimental group
Description:
Participants will receive ZIM, DOM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
Treatment:
Drug: Domvanalimab (DOM)
Drug: Zimberelimab (ZIM)
Drug: Etrumadenant (ETRUMA)
Substudy 01: ZIM + ETRUMA
Experimental group
Description:
Participants will receive ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
Treatment:
Drug: Zimberelimab (ZIM)
Drug: Etrumadenant (ETRUMA)
Substudy 01: ZIM + Platinum Based Chemotherapy
Active Comparator group
Description:
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).
Treatment:
Drug: Carboplatin
Drug: Zimberelimab (ZIM)
Drug: Cisplatin
Drug: Pemetrexed
Drug: Paclitaxel
Drug: Nab-paclitaxel
Substudy 02: SG + ZIM + ETRUMA
Experimental group
Description:
Participants will receive SG, ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
Treatment:
Drug: Zimberelimab (ZIM)
Drug: Sacituzumab govitecan-hziy (SG)
Drug: Etrumadenant (ETRUMA)
Substudy 02: Either Docetaxel or SG (Monotherapy Only)
Active Comparator group
Description:
Participants will receive either Docetaxel or SG until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
Treatment:
Drug: Docetaxel
Drug: Sacituzumab govitecan-hziy (SG)
Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy
Experimental group
Description:
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).
Treatment:
Drug: Carboplatin
Drug: Domvanalimab (DOM)
Drug: Zimberelimab (ZIM)
Drug: Pemetrexed
Drug: Paclitaxel
Substudy 03 - ZIM + Platinum-based Chemotherapy
Experimental group
Description:
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).
Treatment:
Drug: Carboplatin
Drug: Zimberelimab (ZIM)
Drug: Pemetrexed
Drug: Paclitaxel
Substudy 03: Nivolumab + Platinum-based Chemotherapy
Active Comparator group
Description:
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).
Treatment:
Drug: Carboplatin
Drug: Nivolumab
Drug: Pemetrexed
Drug: Paclitaxel

Trial contacts and locations

66

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Central trial contact

Gilead Clinical Study Information Center

Data sourced from clinicaltrials.gov

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