Olaparib and Durvalumab With Carboplatin, Etoposide, and/or Radiation Therapy for the Treatment of Extensive-Stage Small Cell Lung Cancer, PRIO Trial
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|ClinicalTrials.gov Identifier: NCT04728230|
Recruitment Status : Recruiting
First Posted : January 28, 2021
Last Update Posted : April 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Extensive Stage Lung Small Cell Carcinoma Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8||Drug: Carboplatin Biological: Durvalumab Drug: Etoposide Drug: Olaparib Radiation: Radiation Therapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial of PARP Inhibition, Radiation, and Immunotherapy in Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC) - PRIO Trial|
|Actual Study Start Date :||January 5, 2021|
|Estimated Primary Completion Date :||July 1, 2022|
|Estimated Study Completion Date :||July 1, 2022|
Experimental: Treatment (chemo-immunotherapy, radiation therapy)
See detailed description.
Radiation: Radiation Therapy
Undergo consolidative thoracic radiation therapy
- Incidence of dose limiting toxicity [ Time Frame: From start of olaparib, at the end of cycle 6 (each cycle is 28 days) ]Will be assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Toxicity data by type and severity will be summarized in frequency tables.
- Progression-free survival (PFS) [ Time Frame: Time from starting chemo-immunotherapy until disease progression or death from any cause, assessed up to 1 year ]Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. PFS will be compared to the pre-specified parameter obtained from historical data of comparable patients with extensive-stage small cell lung cancer (ES-SCLC) treated with frontline etoposide plus either cisplatin or carboplatin (EP) chemotherapy followed by thoracic radiation. Will be estimated using the Kaplan-Meier method. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox regression model will be applied to evaluate the effect of potential covariates on PFS.
- Overall survival (OS) [ Time Frame: Time from starting chemo-immunotherapy until death from any cause, assessed up to 1 year ]Will be estimated using the Kaplan-Meier method. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox regression model will be applied to evaluate the effect of potential covariates on OS.
- Overall response rate (ORR) [ Time Frame: Up to 1 year ]The patient's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions.
- Intra- and extra-thoracic recurrence rates [ Time Frame: Up to 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04728230
|Contact: Marcelo V Negraofirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Marcelo V. Negrao 713-792-6363 email@example.com|
|Principal Investigator: Marcelo V. Negrao|
|Principal Investigator:||Marcelo V Negrao||M.D. Anderson Cancer Center|