MRTX849 Monotherapy for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Non-Small Cell Lung Cancer+1 MoreMRTX849 Monotherapy - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug, MRTX849, to see if it is effective in treating patients with advanced lung cancer who have a specific gene mutation.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Non Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 13 Secondary · Reporting Duration: 62 months

11 months
Evaluate the clinical activity of MRTX849 in combination with pembrolizumab
To characterize the safety and tolerability of the combination regimen in the selected population.
22 months
Duration of Response (DOR)
Evaluate the efficacy of MRTX849 monotherapy in advanced/metastatic NSCLC with PDL1 <1%, and efficacy of MRTX849 in combination with pembrolizumab, based on the Objective Response Rate (ORR) using RECIST version 1.1
Pharmacokinetics (PK) Blood plasma MRTX849 and potential metabolite concentrations
Phase 2: To characterize the safety and tolerability of study treatments in selected populations
Phase 2: To evaluate secondary efficacy endpoints using the study treatment in selected populations
Phase 2: To evaluate the efficacy of MRTX849 monotherapy and in combination with pembrolizumab administered to patients having advanced/metastatic NSCLC.
Phase 2: To evaluate the pharmacokinetics (PK) of study treatments by measuring blood plasma MRTX849 and potential metabolite concentrations.
To characterize the safety and tolerability of the monotherapy and combination regimen in the selected population.
To evaluate secondary efficacy endpoints using the monotherapy and the combination regimen in the selected population
Non-Small Cell Lung Carcinoma
To evaluate the pharmacokinetics (PK) of MRTX849 administered as monotherapy and in combination with pembrolizumab by measuring blood plasma MRTX849 and potential metabolite concentrations.
62 months
Phase 3: To compare efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab plus chemotherapy
Phase 3: To evaluate health-related quality of life (HRQOL) and lung cancer specific symptoms in the study population
Phase 3: To evaluate secondary efficacy endpoints in the study population
Phase 3: To evaluate the PK of adagrasib administered in the study population
Phase 3: To evaluate the safety and tolerability in the study population

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

8 Treatment Groups

Phase 3 Cohort 4: PD-L1 TPS <50% randomized 1:1 with experimental arm
1 of 8
Phase 2 Cohort 1b: PD-L1 TPS <1%
1 of 8
Phase 3 Cohort 3: PD-L1 TPS<50% randomized 1:1 with comparator arm
1 of 8
Phase 2 Cohort 1a: PD-L1 TPS <1%
1 of 8
Phase 2 Cohort 2: PD-L1 TPS ≥1%
1 of 8
Cohort 1a: PD-L1 TPS <1%
1 of 8
Cohort 2: PD-L1 TPS ≥1%
1 of 8
Cohort 1b: PD-L1 TPS <1%
1 of 8

Active Control

Experimental Treatment

950 Total Participants · 8 Treatment Groups

Primary Treatment: MRTX849 Monotherapy · No Placebo Group · Phase 2 & 3

Phase 2 Cohort 1b: PD-L1 TPS <1%
Drug
Experimental Group · 1 Intervention: MRTX849 Monotherapy · Intervention Types: Drug
Phase 3 Cohort 3: PD-L1 TPS<50% randomized 1:1 with comparator arm
Drug
Experimental Group · 1 Intervention: MRTX849 in Combination with Pembrolizumab · Intervention Types: Drug
Phase 2 Cohort 1a: PD-L1 TPS <1%
Drug
Experimental Group · 1 Intervention: MRTX849 in Combination with Pembrolizumab · Intervention Types: Drug
Phase 2 Cohort 2: PD-L1 TPS ≥1%
Drug
Experimental Group · 1 Intervention: MRTX849 in Combination with Pembrolizumab · Intervention Types: Drug
Cohort 1a: PD-L1 TPS <1%
Drug
Experimental Group · 1 Intervention: MRTX849 in Combination with Pembrolizumab · Intervention Types: Drug
Cohort 2: PD-L1 TPS ≥1%
Drug
Experimental Group · 1 Intervention: MRTX849 in Combination with Pembrolizumab · Intervention Types: Drug
Cohort 1b: PD-L1 TPS <1%
Drug
Experimental Group · 1 Intervention: MRTX849 Monotherapy · Intervention Types: Drug
Phase 3 Cohort 4: PD-L1 TPS <50% randomized 1:1 with experimental arm
Drug
ActiveComparator Group · 1 Intervention: Phase 3 comparator arm · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 62 months

Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor
59 Previous Clinical Trials
6,252 Total Patients Enrolled
Richard L Chao, MDStudy DirectorMirati Therapeutics Inc.
Elise Horvath Walsh, MDStudy DirectorMirati Therapeutics Inc.
Vicky Kang, MDStudy DirectorMirati Therapeutics Inc.
1 Previous Clinical Trials
340 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumours (RECIST).
You have been diagnosed with metastatic non-small cell lung cancer (NSCLC) containing a KRAS G12C mutation and any level of programmed death ligand 1 expression (PD-L1 TPS).
You have a histologically confirmed diagnosis of advanced or metastatic non-squamous NSCLC with KRAS G12C mutation and PD-L1 TPS below 50%.
There is no indication of brain metastases.
You have brain metastases that do not necessitate prompt local treatment.
You have previously undergone treatment for brain metastases and no urgent local therapy is required.