Trial Outcomes & Findings for Post Marketing Surveillance of Nintedanib in Indian Patients With Non-small Cell Lung Cancer (NSCLC) After First-line Therapy (NCT NCT03017885)

Last Updated: 2024-03-25

Results Overview

Incidence of all Adverse drug reactions (ADRs) in nintedanib and docetaxel treated patients. An Adverse Event (AE) was considered as an Adverse drug reaction (ADR) if either the physician who reported the AE or the sponsor assessed its causal relationship as 'related'. The incidence rate were calculated using number of patients with respective events divided by time at risk expressed as \[100 pt -yrs\].

Recruitment status

COMPLETED

Target enrollment

28 participants

Primary outcome timeframe

From first drug administration until 28 days after the last drug administration, up to 586 days.

Results posted on

2024-03-25

Participant Flow

An active surveillance to monitor the real-world safety in Indian patients prescribed nintedanib as per approved Indian Label for the treatment of locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	Nintedanib and Docetaxel: Group A Group A: Non-small cell lung cancer (NSCLC) patients who had started treatment with the approved Indian labels of nintedanib and docetaxel after 23rd January 2017 and had discontinued the drug at the time of participation in the active surveillance.	Nintedanib and Docetaxel: Group B Group B: Non-small cell lung cancer (NSCLC) patients who started treatment with the approved Indian labels of nintedanib and docetaxel after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance.	Nintedanib and Docetaxel: Group C Group C: Non-small cell lung cancer (NSCLC) patients were newly prescribed the approved Indian labels nintedanib and docetaxel at the time of participation in the active surveillance.	Single Agent Docetaxel: Group I Group I: Non-small cell lung cancer (NSCLC) patients who started treatment with docetaxel after 23rd January 2017 and had discontinued the drug at the time of participation in the active surveillance. Patients who received the single agent docetaxel were not followed up after the baseline visit as per the study design.	Single Agent Docetaxel: Group II Group II: Non-small cell lung cancer (NSCLC) patients who had started treatment with docetaxel after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance. Patients who received the single agent docetaxel were not followed up after the baseline visit as per the study design.	Single Agent Docetaxel: Group III Group III: Non-small cell lung cancer (NSCLC) patients who were newly prescribed docetaxel at the time of participation in the active surveillance. Patients who received the single agent docetaxel were not followed up after the baseline visit as per the study design.
Overall Study STARTED	9	5	9	1	3	1
Overall Study COMPLETED	0	0	0	1	3	1
Overall Study NOT COMPLETED	9	5	9	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Nintedanib and Docetaxel: Group A Group A: Non-small cell lung cancer (NSCLC) patients who had started treatment with the approved Indian labels of nintedanib and docetaxel after 23rd January 2017 and had discontinued the drug at the time of participation in the active surveillance.	Nintedanib and Docetaxel: Group B Group B: Non-small cell lung cancer (NSCLC) patients who started treatment with the approved Indian labels of nintedanib and docetaxel after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance.	Nintedanib and Docetaxel: Group C Group C: Non-small cell lung cancer (NSCLC) patients were newly prescribed the approved Indian labels nintedanib and docetaxel at the time of participation in the active surveillance.
Overall Study Adverse Event	2	0	0
Overall Study Progression of disease	4	3	4
Overall Study Other than listed	1	2	1
Overall Study Lost to Follow-up	2	0	3
Overall Study Change to other anti-cancer therapy	0	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nintedanib and Docetaxel: Group A n=9 Participants Group A: Non-small cell lung cancer (NSCLC) patients who had started treatment with the approved Indian labels of nintedanib and docetaxel after 23rd January 2017 and had discontinued the drug at the time of participation in the active surveillance.	Nintedanib and Docetaxel: Group B n=5 Participants Group B: Non-small cell lung cancer (NSCLC) patients who started treatment with the approved Indian labels of nintedanib and docetaxel after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance.	Nintedanib and Docetaxel: Group C n=9 Participants Group C: Non-small cell lung cancer (NSCLC) patients were newly prescribed the approved Indian labels nintedanib and docetaxel at the time of participation in the active surveillance.	Single Agent Docetaxel: Group I n=1 Participants Group I: Non-small cell lung cancer (NSCLC) patients who started treatment with docetaxel after 23rd January 2017 and had discontinued the drug at the time of participation in the active surveillance. Patients who received the single agent docetaxel were not followed up after the baseline visit as per the study design.	Single Agent Docetaxel: Group II n=3 Participants Group II: Non-small cell lung cancer (NSCLC) patients who had started treatment with docetaxel after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance. Patients who received the single agent docetaxel were not followed up after the baseline visit as per the study design.	Single Agent Docetaxel: Group III n=1 Participants Group III: Non-small cell lung cancer (NSCLC) patients who were newly prescribed docetaxel at the time of participation in the active surveillance. Patients who received the single agent docetaxel were not followed up after the baseline visit as per the study design.	Total n=28 Participants Total of all reporting groups
Age, Continuous	59.7 Years STANDARD_DEVIATION 5.8 • n=9 Participants	59.8 Years STANDARD_DEVIATION 9.2 • n=5 Participants	57.0 Years STANDARD_DEVIATION 12.1 • n=9 Participants	39.0 Years STANDARD_DEVIATION NA • n=1 Participants	61.7 Years STANDARD_DEVIATION 11.9 • n=3 Participants	56.0 Years STANDARD_DEVIATION NA • n=1 Participants	58.2 Years STANDARD_DEVIATION 9.6 • n=28 Participants
Sex: Female, Male Female	2 Participants n=9 Participants	3 Participants n=5 Participants	1 Participants n=9 Participants	0 Participants n=1 Participants	1 Participants n=3 Participants	0 Participants n=1 Participants	7 Participants n=28 Participants
Sex: Female, Male Male	7 Participants n=9 Participants	2 Participants n=5 Participants	8 Participants n=9 Participants	1 Participants n=1 Participants	2 Participants n=3 Participants	1 Participants n=1 Participants	21 Participants n=28 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: From first drug administration until 28 days after the last drug administration, up to 586 days.

Population: Only patients who were treated with nintedanib and docetaxel and were included in the treated set (TS). TS: all patients who signed the informed consent form (ICF), met the eligibility criteria and had take at least one dose of study medication. Results are reported for overall nintedanib and doxetaxel group. According to the protcol, it was not planned to compare all 3 groups of nintedanib and docetaxel.

Outcome measures

Outcome measures
Measure	Nintedanib and Docetaxel n=23 Participants Non-small cell lung cancer (NSCLC) patients who had started treatment with the approved Indian labels of nintedanib and docetaxel (all Groups).
Incidence of All Adverse Drug Reactions (ADRs) in Nintedanib and Docetaxel Treated Patients	17.9 Patients per 100 patient years Interval 2.2 to 64.7

PRIMARY outcome

Timeframe: From first drug administration until 28 days after the last drug administration, up to 586 days.

Incidence rate of all Serious Adverse Events (SAEs) in nintedanib and docetaxel treated patients. All Adverse Events (AEs) that occurred between the first intake of nintedanib plus docetaxel and within 28 days (inclusive) after the last intake were considered 'treatment emergent'. The incidence rate were calculated using number of patients with respective events divided by time at risk expressed as \[100 pt -yrs\].

Outcome measures

Outcome measures
Measure	Nintedanib and Docetaxel n=23 Participants Non-small cell lung cancer (NSCLC) patients who had started treatment with the approved Indian labels of nintedanib and docetaxel (all Groups).
Incidence Rate of All Serious Adverse Events (SAEs) in Nintedanib and Docetaxel Treated Patients	25.3 Patients per 100 patient years Interval 12.7 to 45.4

SECONDARY outcome

Timeframe: From first drug administration until 28 days after the last drug administration, up to 586 days.

Percentage of patients who required nintedanib dose reductions.

Outcome measures

Outcome measures
Measure	Nintedanib and Docetaxel n=23 Participants Non-small cell lung cancer (NSCLC) patients who had started treatment with the approved Indian labels of nintedanib and docetaxel (all Groups).
Percentage of Patients Who Required Nintedanib Dose Reductions	4.3 Percentage of Participants

SECONDARY outcome

Timeframe: From first drug administration until last drug administration, up to 558 days.

Number of patients who discontinued study drug permanently due to adverse events.

Outcome measures

Outcome measures
Measure	Nintedanib and Docetaxel n=23 Participants Non-small cell lung cancer (NSCLC) patients who had started treatment with the approved Indian labels of nintedanib and docetaxel (all Groups).
Number of Patients Who Discontinued Study Drug Permanently Due to Adverse Events	2 Participants

Adverse Events

Docetaxel and Nintedanib

Serious events: 9 serious events

Other events: 0 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Docetaxel and Nintedanib n=23 participants at risk Non-small cell lung cancer (NSCLC) patients who had started treatment with the approved Indian labels of nintedanib and docetaxel (all Groups).
Gastrointestinal disorders Gastroenteritis	4.3% 1/23 • From first drug administration until 28 days after the last drug administration, up to 586 days. All-cause mortality: Up to 51.5 months after first drug administration. As defined in protocol safety data was not collected for patients treated with single agent docetaxel as they were not followed up after the baseline visit. There was no plan to compare all 3 nintedanib and docetaxel groups according to the protocol. Only patients who were treated with nintedanib and docetaxel and were included in the treated set (TS). TS: all patients who signed the informed consent form (ICF), met the eligibility criteria and had take at least one dose of study medication.
General disorders Oedema peripheral	4.3% 1/23 • From first drug administration until 28 days after the last drug administration, up to 586 days. All-cause mortality: Up to 51.5 months after first drug administration. As defined in protocol safety data was not collected for patients treated with single agent docetaxel as they were not followed up after the baseline visit. There was no plan to compare all 3 nintedanib and docetaxel groups according to the protocol. Only patients who were treated with nintedanib and docetaxel and were included in the treated set (TS). TS: all patients who signed the informed consent form (ICF), met the eligibility criteria and had take at least one dose of study medication.
General disorders Pyrexia	4.3% 1/23 • From first drug administration until 28 days after the last drug administration, up to 586 days. All-cause mortality: Up to 51.5 months after first drug administration. As defined in protocol safety data was not collected for patients treated with single agent docetaxel as they were not followed up after the baseline visit. There was no plan to compare all 3 nintedanib and docetaxel groups according to the protocol. Only patients who were treated with nintedanib and docetaxel and were included in the treated set (TS). TS: all patients who signed the informed consent form (ICF), met the eligibility criteria and had take at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	4.3% 1/23 • From first drug administration until 28 days after the last drug administration, up to 586 days. All-cause mortality: Up to 51.5 months after first drug administration. As defined in protocol safety data was not collected for patients treated with single agent docetaxel as they were not followed up after the baseline visit. There was no plan to compare all 3 nintedanib and docetaxel groups according to the protocol. Only patients who were treated with nintedanib and docetaxel and were included in the treated set (TS). TS: all patients who signed the informed consent form (ICF), met the eligibility criteria and had take at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	21.7% 5/23 • From first drug administration until 28 days after the last drug administration, up to 586 days. All-cause mortality: Up to 51.5 months after first drug administration. As defined in protocol safety data was not collected for patients treated with single agent docetaxel as they were not followed up after the baseline visit. There was no plan to compare all 3 nintedanib and docetaxel groups according to the protocol. Only patients who were treated with nintedanib and docetaxel and were included in the treated set (TS). TS: all patients who signed the informed consent form (ICF), met the eligibility criteria and had take at least one dose of study medication.
Nervous system disorders Loss of consciousness	4.3% 1/23 • From first drug administration until 28 days after the last drug administration, up to 586 days. All-cause mortality: Up to 51.5 months after first drug administration. As defined in protocol safety data was not collected for patients treated with single agent docetaxel as they were not followed up after the baseline visit. There was no plan to compare all 3 nintedanib and docetaxel groups according to the protocol. Only patients who were treated with nintedanib and docetaxel and were included in the treated set (TS). TS: all patients who signed the informed consent form (ICF), met the eligibility criteria and had take at least one dose of study medication.
Nervous system disorders Unresponsive to stimuli	4.3% 1/23 • From first drug administration until 28 days after the last drug administration, up to 586 days. All-cause mortality: Up to 51.5 months after first drug administration. As defined in protocol safety data was not collected for patients treated with single agent docetaxel as they were not followed up after the baseline visit. There was no plan to compare all 3 nintedanib and docetaxel groups according to the protocol. Only patients who were treated with nintedanib and docetaxel and were included in the treated set (TS). TS: all patients who signed the informed consent form (ICF), met the eligibility criteria and had take at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	4.3% 1/23 • From first drug administration until 28 days after the last drug administration, up to 586 days. All-cause mortality: Up to 51.5 months after first drug administration. As defined in protocol safety data was not collected for patients treated with single agent docetaxel as they were not followed up after the baseline visit. There was no plan to compare all 3 nintedanib and docetaxel groups according to the protocol. Only patients who were treated with nintedanib and docetaxel and were included in the treated set (TS). TS: all patients who signed the informed consent form (ICF), met the eligibility criteria and had take at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.3% 1/23 • From first drug administration until 28 days after the last drug administration, up to 586 days. All-cause mortality: Up to 51.5 months after first drug administration. As defined in protocol safety data was not collected for patients treated with single agent docetaxel as they were not followed up after the baseline visit. There was no plan to compare all 3 nintedanib and docetaxel groups according to the protocol. Only patients who were treated with nintedanib and docetaxel and were included in the treated set (TS). TS: all patients who signed the informed consent form (ICF), met the eligibility criteria and had take at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.3% 1/23 • From first drug administration until 28 days after the last drug administration, up to 586 days. All-cause mortality: Up to 51.5 months after first drug administration. As defined in protocol safety data was not collected for patients treated with single agent docetaxel as they were not followed up after the baseline visit. There was no plan to compare all 3 nintedanib and docetaxel groups according to the protocol. Only patients who were treated with nintedanib and docetaxel and were included in the treated set (TS). TS: all patients who signed the informed consent form (ICF), met the eligibility criteria and had take at least one dose of study medication.

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review Prior to any Submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI´s intellectual property rights.
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