Trial Outcomes & Findings for Olaparib, Cediranib Maleate, and Standard Chemotherapy in Treating Patients With Small Cell Lung Cancer (NCT NCT02899728)

Results Overview

Will be compared to those receiving standard therapy. will use the intention-to-treat framework in which all patients randomized are considered recipients of their randomized assignment, regardless of treatment actually received.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

From second randomization to documented disease progression or death from any cause, whichever occurs first, assessed up to 6 months

Results posted on

2023-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Chemotherapy, Cediranib Maleate, Olaparib) Patients receive carboplatin IV over 60 minutes or cisplatin IV over 60 minutes on day 1 and etoposide IV over 60 minutes on days 1, 2, and 3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients in Arm I who have stable disease, partial, or a complete response are randomized to receive maintenance therapy or no maintenance therapy. Patients in Arm II are assigned to receive maintenance therapy. MAINTENANCE THERAPY: Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28. NO MAINTENANCE THERAPY: Patients are eligible to crossover to receive treatment with cediranib maleate and olaparib upon disease progression at the treating investigator's discretion. Carboplatin: Given IV Cediranib: Given PO Cediranib Maleate: Given PO Cisplatin: Given IV Etoposide: Given IV Olaparib: Given PO	Arm II (Chemotherapy, Cediranib Maleate, Olaparib) Patients receive treatment as in Arm I and also receive cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28. Carboplatin: Given IV Cediranib: Given PO Cediranib Maleate: Given PO Cisplatin: Given IV Etoposide: Given IV Olaparib: Given PO
Overall Study STARTED	5	3
Overall Study COMPLETED	4	2
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Chemotherapy, Cediranib Maleate, Olaparib) Patients receive carboplatin IV over 60 minutes or cisplatin IV over 60 minutes on day 1 and etoposide IV over 60 minutes on days 1, 2, and 3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients in Arm I who have stable disease, partial, or a complete response are randomized to receive maintenance therapy or no maintenance therapy. Patients in Arm II are assigned to receive maintenance therapy. MAINTENANCE THERAPY: Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28. NO MAINTENANCE THERAPY: Patients are eligible to crossover to receive treatment with cediranib maleate and olaparib upon disease progression at the treating investigator's discretion. Carboplatin: Given IV Cediranib: Given PO Cediranib Maleate: Given PO Cisplatin: Given IV Etoposide: Given IV Olaparib: Given PO	Arm II (Chemotherapy, Cediranib Maleate, Olaparib) Patients receive treatment as in Arm I and also receive cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28. Carboplatin: Given IV Cediranib: Given PO Cediranib Maleate: Given PO Cisplatin: Given IV Etoposide: Given IV Olaparib: Given PO
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Chemotherapy, Cediranib Maleate, Olaparib) n=5 Participants Patients receive carboplatin IV over 60 minutes or cisplatin IV over 60 minutes on day 1 and etoposide IV over 60 minutes on days 1, 2, and 3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients in Arm I who have stable disease, partial, or a complete response are randomized to receive maintenance therapy or no maintenance therapy. Patients in Arm II are assigned to receive maintenance therapy. MAINTENANCE THERAPY: Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28. NO MAINTENANCE THERAPY: Patients are eligible to crossover to receive treatment with cediranib maleate and olaparib upon disease progression at the treating investigator's discretion. Carboplatin: Given IV Cediranib: Given PO Cediranib Maleate: Given PO Cisplatin: Given IV Etoposide: Given IV Olaparib: Given PO	Arm II (Chemotherapy, Cediranib Maleate, Olaparib) n=3 Participants Patients receive treatment as in Arm I and also receive cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28. Carboplatin: Given IV Cediranib: Given PO Cediranib Maleate: Given PO Cisplatin: Given IV Etoposide: Given IV Olaparib: Given PO	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=3 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=3 Participants	5 Participants n=8 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	0 Participants n=3 Participants	3 Participants n=8 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=3 Participants	6 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=3 Participants	2 Participants n=8 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	5 participants n=5 Participants	3 participants n=3 Participants	8 participants n=8 Participants

PRIMARY outcome

Timeframe: From second randomization to documented disease progression or death from any cause, whichever occurs first, assessed up to 6 months

Population: Zero participants were analyzed because this trial was closed administratively per CTEP.

Will be compared to those receiving standard therapy. will use the intention-to-treat framework in which all patients randomized are considered recipients of their randomized assignment, regardless of treatment actually received.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From initial randomization to death from any cause, assessed up to 2 years

Population: Zero participants were analyzed because this trial was closed administratively per CTEP.

Additional sensitivity analyses will be conducted on OS to address the effect of potential crossover to olaparib/cediranib on overall survival estimates. These will include rank preserving structural failure time models.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: Zero participants were analyzed because this trial was closed administratively per CTEP.

Assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: Zero participants were analyzed because this trial was closed administratively per CTEP.

Rates in each arm will be provided with exact 95% confidence intervals, and compared using the chi-squared test (or Fisher's exact test, as needed).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 2 years

Assessed by whole exome sequencing. Will be summarized using descriptive statistics.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 2 years

Will be assessed using McNemar's test and Fisher's exact test. More sophisticated analyses may include multivariable logistic regression modeling and/or competing risks analysis.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 2 years

Will be analyzed for association with patient demographics and/or disease characteristics using the Kruskal Wallis test.

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Chemotherapy, Cediranib Maleate, Olaparib)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm II (Chemotherapy, Cediranib Maleate, Olaparib)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jacob Sands, MD

Dana- Farber Cancer Institute

Phone: 617-632-6049

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60