Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)

Conditions

• Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sacituzumab Govitecan-hziy (SG) — DRUG
  Administered intravenously
• Pembrolizumab — DRUG
  Administered intravenously
• Carboplatin — DRUG
  Administered intravenously
• Cisplatin — DRUG
  Administered intravenously

Study Details

The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy (SG), and its dosing in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin), in participants with advanced or metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC).

Key Dates

First listed

Jan 11, 2022

Start date

May 30, 2022

Status verified

Feb 2026

Primary completion

Sep 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

193 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A)
  Participants assigned to Cohorts A according to tumor proportion score (TPS) status will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle.
• Experimental: SG + Pembrolizumab (Cohort B)
  Participants assigned to Cohorts B according to TPS status will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle.
• Experimental: SG + Pembrolizumab + Carboplatin Safety Run-in
  Participants will receive SG (de-escalating dose levels: 10.0 mg/kg, 7.5 mg/kg, or 5.0 mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + carboplatin area under the concentration versus time curve (AUC)5 on Day 1 of a 21-day cycle.
• Experimental: SG + Pembrolizumab + Cisplatin Safety Run-in (Optional)
  Participants will receive SG (either 10 mg/kg or 7.5 mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + cisplatin 75 mg/m\^2 on Day 1 of a 21-day cycle.
• Experimental: SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C)
  Participants assigned to Cohort C according to disease status will receive SG RP2D as determined during the safety run-in cohorts on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + carboplatin AUC5 or cisplatin 75 mg/m\^2 as determined during the safety run-in cohorts on Day 1 of a 21-day cycle.
• Experimental: SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D)
  Participants assigned to Cohort D according to disease status will receive SG RP2D as determined during the safety run-in cohorts on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + carboplatin AUC5 or cisplatin 75 mg/m\^2 as determined during the safety run-in cohorts on Day 1 of a 21-day cycle.
• Experimental: SG + Pembrolizumab + Cisplatin (Cohort E)
  Participants assigned to Cohort E will receive SG RP2D, as determined following safety review of Cohorts C and D, on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + cisplatin 75 mg/ m\^2 on Day 1 of a 21-day cycle.

Primary Outcome Measure

Objective Response Rate as Assessed by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Up to 22 Months ]

Locations (22)

Find similar trials in Anchorage, AK

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