Trial Outcomes & Findings for Nintedanib Compared With Placebo in Treating Against Radiation-Induced Pneumonitis in Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery and Are Undergoing Chemoradiation Therapy (NCT NCT02452463)

Last Updated: 2020-04-06

Results Overview

Will compare the rate of symptomatic radiation pneumonitis in patients who received nintedanib versus placebo. Assessed using the intent-to-treat principle and a one-sided exact test about the Cochran-Mantel-Haenszel correlation and regression test. The grade 2 or higher radiation penumonitis is identified by the Common Terminology Criteria for Adverse Events.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

At 6 months after completion of chemoradiation

Results posted on

2020-04-06

Participant Flow

No participants were enrolled in the "Arm III (Nintedanib, Durvalumab)" Arm - study closed prior to any patients being enrolled in this arm.

Participant milestones

Participant milestones
Measure	Arm I (Nintedanib) Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies	Arm II (Placebo) Beginning 4-8 weeks after completion of radiation therapy, patients receive placebo capsules PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Placebo: Given PO Quality-of-Life Assessment: Ancillary studies
Overall Study STARTED	5	3
Overall Study COMPLETED	3	1
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Nintedanib) Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies	Arm II (Placebo) Beginning 4-8 weeks after completion of radiation therapy, patients receive placebo capsules PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Placebo: Given PO Quality-of-Life Assessment: Ancillary studies
Overall Study Death	1	0
Overall Study Study Suspended	1	0
Overall Study Recommended by DSMB	0	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Nintedanib Compared With Placebo in Treating Against Radiation-Induced Pneumonitis in Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery and Are Undergoing Chemoradiation Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Nintedanib) n=5 Participants Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies	Arm II (Placebo) n=3 Participants Beginning 4-8 weeks after completion of radiation therapy, patients receive placebo capsules PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Placebo: Given PO Quality-of-Life Assessment: Ancillary studies	Arm III (Nintedanib, Durvalumab) Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28 and standard of care durvalumab IV over 60 minutes on days 1 and 15. Treatment with nintedanib repeats every 28 days for up to 6 cycles and treatment with durvalumab repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies	Total n=8 Participants Total of all reporting groups
Age, Continuous	64.40 years STANDARD_DEVIATION 5.94 • n=5 Participants	68.00 years STANDARD_DEVIATION 4.58 • n=7 Participants	—	65.75 years STANDARD_DEVIATION 5.44 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	1 Participants n=7 Participants	—	5 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	—	3 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	3 Participants n=7 Participants	—	8 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	3 participants n=7 Participants	—	8 participants n=4 Participants
Body Mass Index (BMI)	21.75 kg/m2 STANDARD_DEVIATION 5.47 • n=5 Participants	32.15 kg/m2 STANDARD_DEVIATION 3.84 • n=7 Participants	—	25.65 kg/m2 STANDARD_DEVIATION 7.09 • n=4 Participants
Chemotherapy CARBOPLATIN + PACLITAXEL (TAXOL)	2 Participants n=5 Participants	1 Participants n=7 Participants	—	3 Participants n=4 Participants
Chemotherapy CARBOPLATIN + PEMETREXED	1 Participants n=5 Participants	2 Participants n=7 Participants	—	3 Participants n=4 Participants
Chemotherapy CISPLATIN + ETOPOSIDE (VP-16)	1 Participants n=5 Participants	0 Participants n=7 Participants	—	1 Participants n=4 Participants
Chemotherapy CISPLATIN + PEMETREXED	1 Participants n=5 Participants	0 Participants n=7 Participants	—	1 Participants n=4 Participants
Smoking Status Current	2 Participants n=5 Participants	1 Participants n=7 Participants	—	3 Participants n=4 Participants
Smoking Status Former	2 Participants n=5 Participants	2 Participants n=7 Participants	—	4 Participants n=4 Participants
Smoking Status Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	—	1 Participants n=4 Participants
Force Expiratory Volume in 1 Second (FEV1)	66.70 Percentage of Predicted FEV1 STANDARD_DEVIATION 29.59 • n=5 Participants	72.67 Percentage of Predicted FEV1 STANDARD_DEVIATION 6.81 • n=7 Participants	—	68.94 Percentage of Predicted FEV1 STANDARD_DEVIATION 22.87 • n=4 Participants
Forced Vital Capacity (FVC)	91.72 Percentage of Predicted FVC STANDARD_DEVIATION 26.74 • n=5 Participants	82.93 Percentage of Predicted FVC STANDARD_DEVIATION 5.97 • n=7 Participants	—	88.43 Percentage of Predicted FVC STANDARD_DEVIATION 20.96 • n=4 Participants
Diffusing Capacity for Carbon Monoxide (DLCO)	60.52 Percentage of Predicted DLCO STANDARD_DEVIATION 27.21 • n=5 Participants	77.93 Percentage of Predicted DLCO STANDARD_DEVIATION 10.04 • n=7 Participants	—	67.05 Percentage of Predicted DLCO STANDARD_DEVIATION 23.09 • n=4 Participants
peak expiratory flow (PEF)	67.22 Percentage of Predicted PEF STANDARD_DEVIATION 33.78 • n=5 Participants	74.90 Percentage of Predicted PEF STANDARD_DEVIATION 15.89 • n=7 Participants	—	70.10 Percentage of Predicted PEF STANDARD_DEVIATION 27.20 • n=4 Participants
total lung capacity (TLC)	110.60 Percentage of Predicted TLC STANDARD_DEVIATION 18.29 • n=5 Participants	99.17 Percentage of Predicted TLC STANDARD_DEVIATION 8.96 • n=7 Participants	—	106.31 Percentage of Predicted TLC STANDARD_DEVIATION 15.78 • n=4 Participants
Eastern Cooperative Oncology Group Performance Status(ECOG) Fully active	3 Participants n=5 Participants	0 Participants n=7 Participants	—	3 Participants n=4 Participants
Eastern Cooperative Oncology Group Performance Status(ECOG) Restricted in physically strenuous activity	2 Participants n=5 Participants	3 Participants n=7 Participants	—	5 Participants n=4 Participants

PRIMARY outcome

Timeframe: At 6 months after completion of chemoradiation

Population: Study was terminated prior to enrollment in Arm 3.

Outcome measures

Outcome measures
Measure	Arm I (Nintedanib) n=5 Participants Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies	Arm II (Placebo) n=3 Participants Beginning 4-8 weeks after completion of radiation therapy, patients receive placebo capsules PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Placebo: Given PO Quality-of-Life Assessment: Ancillary studies	Arm III (Nintedanib, Durvalumab) Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28 and standard of care durvalumab IV over 60 minutes on days 1 and 15. Treatment with nintedanib repeats every 28 days for up to 6 cycles and treatment with durvalumab repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies
Portion of Common Terminology Criteria for Adverse Events Grade 2 or Higher Radiation Pneumonitis	0.00 proportion of participants	0.67 proportion of participants	—

SECONDARY outcome

Timeframe: Up to 2.5 years post-treatment

Population: Study was discontinued prior to subjects being enrolled in Arm III

The frequency of toxicities will be tabulated by grade.

Outcome measures

Outcome measures
Measure	Arm I (Nintedanib) n=5 Participants Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies	Arm II (Placebo) n=3 Participants Beginning 4-8 weeks after completion of radiation therapy, patients receive placebo capsules PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Placebo: Given PO Quality-of-Life Assessment: Ancillary studies	Arm III (Nintedanib, Durvalumab) Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28 and standard of care durvalumab IV over 60 minutes on days 1 and 15. Treatment with nintedanib repeats every 28 days for up to 6 cycles and treatment with durvalumab repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies
Number of Participants With Adverse Events, Graded According to Common Terminology Criteria for Adverse Events Version 4.0 Grade 1 Maximum AE	2 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events, Graded According to Common Terminology Criteria for Adverse Events Version 4.0 Grade 2 Maximum AE	1 Participants	1 Participants	0 Participants
Number of Participants With Adverse Events, Graded According to Common Terminology Criteria for Adverse Events Version 4.0 Grade 3 Maximum AE	1 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events, Graded According to Common Terminology Criteria for Adverse Events Version 4.0 No Treatmetn Related AE	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 year survival, with follow-up assessed up to 2.5 years post-treatment

Population: Study was terminated prior to enrollment in Arm 3.

Overall survival will be reported using standard Kaplan-Meier methods. Comparisons of overall survival between study arms may utilize the two-sided stratified log-rank test.

Outcome measures

Outcome measures
Measure	Arm I (Nintedanib) n=5 Participants Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies	Arm II (Placebo) n=3 Participants Beginning 4-8 weeks after completion of radiation therapy, patients receive placebo capsules PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Placebo: Given PO Quality-of-Life Assessment: Ancillary studies	Arm III (Nintedanib, Durvalumab) Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28 and standard of care durvalumab IV over 60 minutes on days 1 and 15. Treatment with nintedanib repeats every 28 days for up to 6 cycles and treatment with durvalumab repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies
Overall Survival	53.0 Percent survival at 1 year Interval 7.0 to 86.0	100.0 Percent survival at 1 year Interval 100.0 to 100.0	—

SECONDARY outcome

Timeframe: 1 year progression-free survival, with follow-up assessed up to 2.5 years post-treatment

Population: Study was terminated prior to enrollment in Arm 3.

Progression-free survival will be reported using standard Kaplan-Meier methods. Comparisons of progression-free survival between study arms may utilize the two-sided stratified log-rank test.

Outcome measures

Outcome measures
Measure	Arm I (Nintedanib) n=5 Participants Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies	Arm II (Placebo) n=3 Participants Beginning 4-8 weeks after completion of radiation therapy, patients receive placebo capsules PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Placebo: Given PO Quality-of-Life Assessment: Ancillary studies	Arm III (Nintedanib, Durvalumab) Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28 and standard of care durvalumab IV over 60 minutes on days 1 and 15. Treatment with nintedanib repeats every 28 days for up to 6 cycles and treatment with durvalumab repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies
Progression-free Survival	25.0 Percent survival at 1 year Interval 1.0 to 67.0	100.0 Percent survival at 1 year Interval 100.0 to 100.0	—

SECONDARY outcome

Timeframe: Baseline up to 2.5 years post-treatment

Population: Study was terminated prior to enrollment in Arm 3. For Arms 1 and 2, not all follow-up tests were completed.

Percent changes in the quality of life and symptom scores may be compared between study arms using the Wilcoxon rank sum or independent sample t-tests, as appropriate. The quality of life scores are obtained using the Lung Cancer Symptom Scale (LCSS) The scores range from 0 to 68, where 0 indicates poor quality of life and 68 indicates good quality of life. The percent change from baseline was calculated as 100\*(post treatment - baseline) / baseline.

Outcome measures

Outcome measures
Measure	Arm I (Nintedanib) n=2 Participants Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies	Arm II (Placebo) n=2 Participants Beginning 4-8 weeks after completion of radiation therapy, patients receive placebo capsules PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Placebo: Given PO Quality-of-Life Assessment: Ancillary studies	Arm III (Nintedanib, Durvalumab) Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28 and standard of care durvalumab IV over 60 minutes on days 1 and 15. Treatment with nintedanib repeats every 28 days for up to 6 cycles and treatment with durvalumab repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies
Percent Changes in Overall Quality of Life and Symptom Scores	110.00 percent change Standard Deviation 70.71	-16.35 percent change Standard Deviation 12.24	—

SECONDARY outcome

Timeframe: Baseline up to 2.5 years post-treatment

Population: Study was terminated prior to enrollment in Arm 3. For Arms 1 and 2, not all follow-up tests were completed.

Percent change in pulmonary function test, relative to baseline, will be evaluated within each study arm using the Wilcoxon signed rank or paired t-tests, as appropriate. Changes in pulmonary function tests may be compared between study arms using the Wilcoxon rank sum or independent sample t-tests, as appropriate.

Outcome measures

Outcome measures
Measure	Arm I (Nintedanib) n=2 Participants Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies	Arm II (Placebo) n=2 Participants Beginning 4-8 weeks after completion of radiation therapy, patients receive placebo capsules PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Placebo: Given PO Quality-of-Life Assessment: Ancillary studies	Arm III (Nintedanib, Durvalumab) Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28 and standard of care durvalumab IV over 60 minutes on days 1 and 15. Treatment with nintedanib repeats every 28 days for up to 6 cycles and treatment with durvalumab repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies
Percent Change in Pulmonary Function Tests	-28.29 percent of change Standard Deviation 13.43	11.02 percent of change Standard Deviation 8.59	—

SECONDARY outcome

Timeframe: Baseline up to 2.5 years post-treatment

Population: Study was terminated prior to enrollment in Arm 3. For Arms 1 and 2, not all follow-up tests were completed.

Changes in radiation pneumonitis scores, relative to baseline, will be evaluated within each study arm using the Wilcoxon signed rank or paired t-tests, as appropriate. Changes in radiation pneumonitis scores may be compared between study arms using the Wilcoxon rank sum or independent sample t-tests, as appropriate. The radiation pneumonitis scores were obtained using semi quantitative analysis will be performed for the presence of ground-glass opacity, consolidation, reticulation, mosaic perfusion, traction bronchiectasis and honeycombing for each lung zone and scored on a four point scale (0 = no involvement, 1 ≤ 25%; 2 = 26 50%; 3 = 51 75% and 4 ≥ 76%). The scores are averaged across two radiologists.

Outcome measures

Outcome measures
Measure	Arm I (Nintedanib) n=4 Participants Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies	Arm II (Placebo) n=2 Participants Beginning 4-8 weeks after completion of radiation therapy, patients receive placebo capsules PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Placebo: Given PO Quality-of-Life Assessment: Ancillary studies	Arm III (Nintedanib, Durvalumab) Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28 and standard of care durvalumab IV over 60 minutes on days 1 and 15. Treatment with nintedanib repeats every 28 days for up to 6 cycles and treatment with durvalumab repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies
Changes in Radiation Pneumonitis Scores	0.50 score on a scale Standard Deviation 0.58	0.75 score on a scale Standard Deviation 0.35	—

SECONDARY outcome

Timeframe: Up to 2.5 years post-treatment

Population: Study was terminated prior to enrollment in Arm 3.

Complete response and complete/partial response rates will be reported by study arm and chemotherapy regimen using Wilson 95% confidence intervals. The responses rates will be compared between study arms using the Cochran-Mantel-Haenszel exact test. The objective tumor response was assessed using RECIST 1.1: 1. Complete Response (CR): Disappearance of all target lesions. Any lymph nodes must have a reduction in short axis to \< 10 mm. 2. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 3. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions. The appearance of one or more new lesions is also considered progression. 4. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameter while on study. Overall response = CR + PR.

Outcome measures

Outcome measures
Measure	Arm I (Nintedanib) n=5 Participants Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies	Arm II (Placebo) n=3 Participants Beginning 4-8 weeks after completion of radiation therapy, patients receive placebo capsules PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Placebo: Given PO Quality-of-Life Assessment: Ancillary studies	Arm III (Nintedanib, Durvalumab) Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28 and standard of care durvalumab IV over 60 minutes on days 1 and 15. Treatment with nintedanib repeats every 28 days for up to 6 cycles and treatment with durvalumab repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies
Responses Rates SD/PD	5 Participants	3 Participants	—
Responses Rates CR/PR	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Up to 97 days post-treatment

Population: Due to early termination of the study, the biomarker data was never collected and analyzed.

The tethered cationic lipoplex nanoparticle biochip, microfluidic cationic lipoplex nanoparticle biochip and real-time quantitative reverse transcription-polymerase chain reaction measurements for the expression of micro ribonucleic acid -1, -21, -127 and -155 will be made. The micro ribonucleic acid expressions, vitamin D levels, and mitochondrial deoxyribonucleic acid levels will be treated as continuous and reported by radiation pneumonitis status using the mean, median and standard deviation. Comparisons will be made between groups using a two-sided permutation t-test.

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Nintedanib)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 2 deaths

Arm II (Placebo)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Arm III (Nintedanib, Durvalumab)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Nintedanib) n=5 participants at risk Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies	Arm II (Placebo) n=3 participants at risk Beginning 4-8 weeks after completion of radiation therapy, patients receive placebo capsules PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Placebo: Given PO Quality-of-Life Assessment: Ancillary studies	Arm III (Nintedanib, Durvalumab) Beginning 4-8 weeks after completion of radiation therapy, patients receive nintedanib PO BID on days 1-28 and standard of care durvalumab IV over 60 minutes on days 1 and 15. Treatment with nintedanib repeats every 28 days for up to 6 cycles and treatment with durvalumab repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Nintedanib: Given PO Quality-of-Life Assessment: Ancillary studies
Infections and infestations Lung infection	20.0% 1/5 • Number of events 2 • From start date of intervention until 30 days after the last treatment intervention, up to 2.5 years. All treated patients in Arms I and II. No participants were enrolled in the "Arm III (Nintedanib, Durvalumab)" Arm, therefore no adverse events are reported.	0.00% 0/3 • From start date of intervention until 30 days after the last treatment intervention, up to 2.5 years. All treated patients in Arms I and II. No participants were enrolled in the "Arm III (Nintedanib, Durvalumab)" Arm, therefore no adverse events are reported.	— 0/0 • From start date of intervention until 30 days after the last treatment intervention, up to 2.5 years. All treated patients in Arms I and II. No participants were enrolled in the "Arm III (Nintedanib, Durvalumab)" Arm, therefore no adverse events are reported.
Vascular disorders Haemorrhage	20.0% 1/5 • Number of events 1 • From start date of intervention until 30 days after the last treatment intervention, up to 2.5 years. All treated patients in Arms I and II. No participants were enrolled in the "Arm III (Nintedanib, Durvalumab)" Arm, therefore no adverse events are reported.	0.00% 0/3 • From start date of intervention until 30 days after the last treatment intervention, up to 2.5 years. All treated patients in Arms I and II. No participants were enrolled in the "Arm III (Nintedanib, Durvalumab)" Arm, therefore no adverse events are reported.	— 0/0 • From start date of intervention until 30 days after the last treatment intervention, up to 2.5 years. All treated patients in Arms I and II. No participants were enrolled in the "Arm III (Nintedanib, Durvalumab)" Arm, therefore no adverse events are reported.

Other adverse events

Additional Information

CTRP/CT.gov Registry Coordnator

Roswell Park

Phone: 716-845-1073

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place