A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination with Other Anti-Cancer Therapies in Patients with Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer with a KRAS G12C Mutation

Conditions

Untreated Advanced or Metastatic Non-Small Cell Lung Cancer

Brief summary

1. Occurrence of adverse events, 2. Change from baseline at each visit in targeted safety parameters

Detailed description

1. Objective response rate, 2. Duration of response, 3. Progression free survival, 4. Presence, frequency of occurrence, severity, and/or degree of interference with daily function of symptomatic side effects as assessed through use of the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO‑CTCAE), 5. Change from baseline in symptomatic side effects, as assessed through use of the PRO-CTCAE, 6. Proportion of participants reporting "frequent" or "almost constant" diarrhea during the first three cycles of treatment according to the PRO-CTCAE criteria, 7. Proportion of participants reporting "severe" or "very severe" nausea or vomiting during the first three cycles of treatment according to the PRO-CTCAE, 8. Frequency of participant's response of the degree they are troubled with treatment symptoms, as assessed through use of the single-item European Organisation for Research and Treatment of Cancer (EORTC) Item List 46 (IL46), 9. Plasma concentration of divarasib at specified timepoints, 10. Recommended dose of divarasib in combination with pembrolizumab (Cohort A) or pembrolizumab plus platinum-based chemotherapy and pemetrexed (Cohort B) based on the totality of safety, activity, and PK data

Related papers

No related papers found yet.

Interventions

DRUGCARBOPLATINE ACCORD 10 mg/ml

DRUGsolution pour perfusion

DRUGRO 743-5846/F04

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion.

DRUGALIMTA 500 mg powder for concentrate for solution for infusion

DRUGBudenofalk 3mg magensaftresistente Hartkapseln

DRUGPemetrexed Accord 25 mg/ml concentrate for solution for infusion

DRUGPEMETREXED

DRUGCisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung

DRUGCARBO-cell® 10 mg/ml Infusionslösung

DRUGKonzentrat zur Herstellung einer Infusionslösung

DRUGRO 743-5846/F07

DRUGRO 743-5846/F06

DRUGALIMTA 100 mg powder for concentrate for solution for infusion

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGCarboplatin-GRY® 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCISPLATINE ACCORD 1 mg/ml

DRUGsolution à diluer pour perfusion

DRUGCisplatin Teva® 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGPemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Occurrence of adverse events, 2. Change from baseline at each visit in targeted safety parameters	—

Secondary

Measure	Time frame
1. Objective response rate, 2. Duration of response, 3. Progression free survival, 4. Presence, frequency of occurrence, severity, and/or degree of interference with daily function of symptomatic side effects as assessed through use of the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO‑CTCAE), 5. Change from baseline in symptomatic side effects, as assessed through use of the PRO-CTCAE, 6. Proportion of participants reporting "frequent" or "almost constant" diarrhea during the first three cycles of treatment according to the PRO-CTCAE criteria, 7. Proportion of participants reporting "severe" or "very severe" nausea or vomiting during the first three cycles of treatment according to the PRO-CTCAE, 8. Frequency of participant's response of the degree they are troubled with treatment symptoms, as assessed through use of the single-item European Organisation for Research and Treatment of Cancer (EORTC) Item List 46 (IL46), 9. Plasma concentration of divarasi	—

Measure

Time frame

1. Objective response rate, 2. Duration of response, 3. Progression free survival, 4. Presence, frequency of occurrence, severity, and/or degree of interference with daily function of symptomatic side effects as assessed through use of the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO‑CTCAE), 5. Change from baseline in symptomatic side effects, as assessed through use of the PRO-CTCAE, 6. Proportion of participants reporting "frequent" or "almost constant" diarrhea during the first three cycles of treatment according to the PRO-CTCAE criteria, 7. Proportion of participants reporting "severe" or "very severe" nausea or vomiting during the first three cycles of treatment according to the PRO-CTCAE, 8. Frequency of participant's response of the degree they are troubled with treatment symptoms, as assessed through use of the single-item European Organisation for Research and Treatment of Cancer (EORTC) Item List 46 (IL46), 9. Plasma concentration of divarasi

—

Countries

Belgium, Italy, Netherlands, Poland, Spain, Sweden

Outcome results

None listed