Trial Outcomes & Findings for Olaparib (LYNPARZA) Plus Durvalumab (IMFINZI) in EGFR-Mutated Adenocarcinomas That Transform to Small Cell Lung Cancer (SCLC) and Other Neuroendocrine Tumors (NCT NCT04538378)

Last Updated: 2025-01-27

Results Overview

BOR is the best response recorded from the start of the treatment until disease progression/recurrence. The clinical response rate of evaluable participants will be reported along with a 95% confidence interval according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Disease progression; an average of 53 days

Results posted on

2025-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	1/Arm 1: Combination of Durvalumab and Olaparib Dose Level 1: Durvalumab (1,500 mg) will be given intravenous (IV) every 28 days and olaparib (300 mg twice a day (BID) for total daily dose of 600 mg) will be administered orally on every day of every cycle.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Olaparib (LYNPARZA) Plus Durvalumab (IMFINZI) in EGFR-Mutated Adenocarcinomas That Transform to Small Cell Lung Cancer (SCLC) and Other Neuroendocrine Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1/Arm 1: Combination of Durvalumab and Olaparib n=4 Participants Dose Level 1: Durvalumab (1,500 mg) will be given intravenous (IV) every 28 days and olaparib (300 mg twice a day (BID) for total daily dose of 600 mg) will be administered orally on every day of every cycle.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 10.23 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Disease progression; an average of 53 days

Outcome measures

Outcome measures
Measure	1/Arm 1: Combination of Durvalumab and Olaparib n=4 Participants Dose Level 1: Durvalumab (1,500 mg) will be given intravenous (IV) every 28 days and olaparib (300 mg twice a day (BID) for total daily dose of 600 mg) will be administered orally on every day of every cycle.	Grade 2 Non-Serious 1/Arm 1: Combination of Durvalumab and Olaparib	Grade 3 Non-Serious 1/Arm 1: Combination of Durvalumab and Olaparib	Grade 4 Non-Serious 1/Arm 1: Combination of Durvalumab and Olaparib	Any Grade Serious 1/Arm 1: Combination of Durvalumab and Olaparib
Best Overall Response (BOR) Complete Response	0 Proportion of participants Interval 0.0 to 0.0	—	—	—	—
Best Overall Response (BOR) Partial Response	0 Proportion of participants Interval 0.0 to 0.0	—	—	—	—
Best Overall Response (BOR) Progressive Disease	1.0 Proportion of participants Interval 1.0 to 1.0	—	—	—	—
Best Overall Response (BOR) Stable Disease	0 Proportion of participants Interval 0.0 to 0.0	—	—	—	—

SECONDARY outcome

Timeframe: Disease progression, an average of 7 weeks

PFS is defined as the time interval from start of treatment to documented evidence of disease progression assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). PFS will be estimated by the Kaplan-Meier method. The median PFS will be reported along with a 95% confidence interval. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions.

Outcome measures

Outcome measures
Measure	1/Arm 1: Combination of Durvalumab and Olaparib n=4 Participants Dose Level 1: Durvalumab (1,500 mg) will be given intravenous (IV) every 28 days and olaparib (300 mg twice a day (BID) for total daily dose of 600 mg) will be administered orally on every day of every cycle.	Grade 2 Non-Serious 1/Arm 1: Combination of Durvalumab and Olaparib	Grade 3 Non-Serious 1/Arm 1: Combination of Durvalumab and Olaparib	Grade 4 Non-Serious 1/Arm 1: Combination of Durvalumab and Olaparib	Any Grade Serious 1/Arm 1: Combination of Durvalumab and Olaparib
Progression-free Survival (PFS)	53 Days Interval 35.0 to 55.0	—	—	—	—

SECONDARY outcome

Timeframe: Treatment phase, an average of 12 weeks

Participants will be assessed for toxicity by reporting the grades of toxicity and the type of toxicity observed for all participants. Toxicity was assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.

Outcome measures

Outcome measures
Measure	1/Arm 1: Combination of Durvalumab and Olaparib n=4 Participants Dose Level 1: Durvalumab (1,500 mg) will be given intravenous (IV) every 28 days and olaparib (300 mg twice a day (BID) for total daily dose of 600 mg) will be administered orally on every day of every cycle.	Grade 2 Non-Serious n=4 Participants 1/Arm 1: Combination of Durvalumab and Olaparib	Grade 3 Non-Serious n=4 Participants 1/Arm 1: Combination of Durvalumab and Olaparib	Grade 4 Non-Serious n=4 Participants 1/Arm 1: Combination of Durvalumab and Olaparib	Any Grade Serious n=4 Participants 1/Arm 1: Combination of Durvalumab and Olaparib
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Anemia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Anorexia	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Anxiety	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Constipation	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Cough	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Dizziness	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Dyspnea	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Fatigue	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Headache	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Superficial thrombophlebitis	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Hyperglycemia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Hyperkalemia	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Hypokalemia	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Hyponatremia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Lipase increased	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Lymphocyte count decreased	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Nausea	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Pain	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Paresthesia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Serum amylase increased	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Thyroid stimulating hormone increased	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Tremor	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Urticaria	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 1, 2, 3, 4 and/or 5 Serious and/or Non-serious Toxicity Vomiting	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At death, an average of 275 days

OS is defined as the time between the first day of treatment to the day of death. OS will be estimated by the Kaplan-Meier method. The median OS will be reported along with a 95% confidence interval.

Outcome measures

Outcome measures
Measure	1/Arm 1: Combination of Durvalumab and Olaparib n=4 Participants Dose Level 1: Durvalumab (1,500 mg) will be given intravenous (IV) every 28 days and olaparib (300 mg twice a day (BID) for total daily dose of 600 mg) will be administered orally on every day of every cycle.	Grade 2 Non-Serious 1/Arm 1: Combination of Durvalumab and Olaparib	Grade 3 Non-Serious 1/Arm 1: Combination of Durvalumab and Olaparib	Grade 4 Non-Serious 1/Arm 1: Combination of Durvalumab and Olaparib	Any Grade Serious 1/Arm 1: Combination of Durvalumab and Olaparib
Overall Survival (OS)	284 Days Interval 136.0 to 397.0	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	1/Arm 1: Combination of Durvalumab and Olaparib n=4 Participants Dose Level 1: Durvalumab (1,500 mg) will be given intravenous (IV) every 28 days and olaparib (300 mg twice a day (BID) for total daily dose of 600 mg) will be administered orally on every day of every cycle.	Grade 2 Non-Serious 1/Arm 1: Combination of Durvalumab and Olaparib	Grade 3 Non-Serious 1/Arm 1: Combination of Durvalumab and Olaparib	Grade 4 Non-Serious 1/Arm 1: Combination of Durvalumab and Olaparib	Any Grade Serious 1/Arm 1: Combination of Durvalumab and Olaparib
Number of Participants With Serious and/or Non-Serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).	4 Participants	—	—	—	—

Adverse Events

1/Arm 1: Combination of Durvalumab and Olaparib

Serious events: 0 serious events

Other events: 4 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	1/Arm 1: Combination of Durvalumab and Olaparib n=4 participants at risk Dose Level 1: Durvalumab (1,500 mg) will be given intravenous (IV) every 28 days and olaparib (300 mg twice a day (BID) for total daily dose of 600 mg) will be administered orally on every day of every cycle.
Blood and lymphatic system disorders Anemia	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Metabolism and nutrition disorders Anorexia	50.0% 2/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Psychiatric disorders Anxiety	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Gastrointestinal disorders Constipation	75.0% 3/4 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Nervous system disorders Dizziness	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 2/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
General disorders Fatigue	75.0% 3/4 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Nervous system disorders Headache	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Metabolism and nutrition disorders Hyperglycemia	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Metabolism and nutrition disorders Hyperkalemia	25.0% 1/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Metabolism and nutrition disorders Hypokalemia	50.0% 2/4 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Metabolism and nutrition disorders Hyponatremia	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Investigations Lipase increased	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Investigations Lymphocyte count decreased	75.0% 3/4 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Gastrointestinal disorders Nausea	75.0% 3/4 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
General disorders Pain	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Nervous system disorders Paresthesia	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Investigations Serum amylase increased	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Vascular disorders Superficial thrombophlebitis	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Investigations Thyroid stimulating hormone increased	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Nervous system disorders Tremor	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Skin and subcutaneous tissue disorders Urticaria	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.
Gastrointestinal disorders Vomiting	25.0% 1/4 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 275 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 11.4 weeks.

Additional Information

Dr. Anish Thomas

National Cancer Institute

Phone: 240-760-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place