Study of Durvalumab or Durvalumab Plus Chemotherapy in Kras Mutation Positive and PD-L1 High (≥ 5… (NCT04470674) | Clinical Trial Compass
WithdrawnPhase 2
Study of Durvalumab or Durvalumab Plus Chemotherapy in Kras Mutation Positive and PD-L1 High (≥ 50%) NSCLC Patients
Stopped: Lack of Accrual
United States0Started 2021-04-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
* Age ≥ 18 years at the time of consent.
* Body weight \> 30 kg. If body weight falls to 30 kg or below during the study, the subject will be removed from study drugs.
* ECOG Performance Status of 0-1 within 7 days prior to registration.
* Life expectancy of ≥ 12 weeks.
* Histological or cytological evidence of stage IV Kras mutation positive non-squamous NSCLC.
* Patients who have recurrence following treatment for earlier stages of NSCLC are eligible provided the recurrence has not occurred within 12 months of completing prior therapy.
* Patient's tumor must be known to be PD-L1 high (≥ 50%). SP-142 assay will not be accepted. See Section 8.1 for additional information regarding this result.
* Measurable disease according to RECIST v1.1 criteria within 4 weeks of study registration.
* Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 14 days prior to registration.
* Absolute Neutrophil Count (ANC) ≥ 1.5 K/mm3
* Hemoglobin (Hgb) ≥ 9.0 g/dL
* Platelets ≥ 75 k/mm3
* Calculated creatinine clearance ≥ 45 cc/min using the Cockcroft-Gault formula
* Bilirubin ≤ 1.5 × upper limit of normal (ULN) This will not apply to subjects with clinical diagnosis of Gilbert's syndrome (persistent or recurrent hyperbilirubinemi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.