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

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 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

593 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)

593 participants in 10 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: Sacituzumab govitecan-hziy (SG)
Drug: Zimberelimab (ZIM)
Drug: Domvanalimab (DOM)
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: Zimberelimab (ZIM)
Drug: Etrumadenant (ETRUMA)
Drug: Domvanalimab (DOM)
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: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG)
Experimental group
Description:
Participants will receive ZIM and SG until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met.
Treatment:
Drug: Sacituzumab govitecan-hziy (SG)
Drug: Zimberelimab (ZIM)
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: Pemetrexed
Drug: Zimberelimab (ZIM)
Drug: Cisplatin
Drug: Nab-paclitaxel
Drug: Paclitaxel
Drug: Carboplatin
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: Sacituzumab govitecan-hziy (SG)
Drug: Zimberelimab (ZIM)
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: Sacituzumab govitecan-hziy (SG)
Drug: Docetaxel
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: Pemetrexed
Drug: Zimberelimab (ZIM)
Drug: Domvanalimab (DOM)
Drug: Paclitaxel
Drug: Carboplatin
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: Pemetrexed
Drug: Zimberelimab (ZIM)
Drug: Paclitaxel
Drug: Carboplatin
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: Pemetrexed
Drug: Nivolumab
Drug: Paclitaxel
Drug: Carboplatin

Trial contacts and locations

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Central trial contact

Gilead Clinical Study Information Center

Data sourced from clinicaltrials.gov

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