Trials / Withdrawn
WithdrawnNCT04470674
Study of Durvalumab or Durvalumab Plus Chemotherapy in Kras Mutation Positive and PD-L1 High (≥ 50%) NSCLC Patients
Randomized Phase II Study of Durvalumab or Durvalumab Plus Chemotherapy in Kras Mutation Positive and PD-L1 High (≥ 50%) NSCLC Patients
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Shirish M Gadgeel · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a two arm, randomized, phase II study of patients with advanced KRAS mutation positive and PD-L1 high NSCLC who have not received therapy for advanced stage disease. Patients will be randomized between Arm A and Arm B treatment. Arm A treatment will consist of durvalumab every 4 weeks for 13 cycles. Arm B treatment will consist of durvalumab with chemotherapy every 3 weeks for 4 cycles followed by durvalumab with pemetrexed every 3 weeks for 13 cycles.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Durvalumab | Durvalumab 1500 mg |
| DRUG | Carboplatin | carboplatin AUC 5 |
| DRUG | Pemetrexed | pemetrexed 500 mg/m2 |
Timeline
- Start date
- 2021-04-06
- Primary completion
- 2021-06-08
- Completion
- 2021-06-08
- First posted
- 2020-07-14
- Last updated
- 2022-03-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04470674. Inclusion in this directory is not an endorsement.