Non-small Cell Lung Cancer
Conditions
Brief summary
This active surveillance aims to collect the safety data of 100 NSCLC patients treated with nintedanib per the approved Indian label within 2 years from the date of commercial availability of the drug in India (23rd January 2017). The objective is to look at the safety of nintedanib in the real world setting.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 years of age with locally advanced and/or metastatic NSCLC of stage IIIB or IV, or recurrent NSCLC and adenocarcinoma histology after first line chemotherapy who have initiated or will initiate nintedanib & docetaxel according to the package insert after the commercial availability of drug in India (23rd January 2017). * Patients in whom it is possible to obtain voluntary informed consent from either the patient or patient's legally authorised representative (applicable for Group B and C patients). * Patients in whom data collection is possible from the medical records (applicable for Group A and B patients). * Further inclusion criteria apply.
Exclusion criteria
* Patients who were previously treated with nintedanib. * Patients who are positive for endothelial growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements * Patients who are participating in a clinical trial. * Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of All Adverse Drug Reactions (ADRs) in Nintedanib and Docetaxel Treated Patients | From first drug administration until 28 days after the last drug administration, up to 586 days. | 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 \[100 pt -yrs\]. |
| Incidence Rate of All Serious Adverse Events (SAEs) in Nintedanib and Docetaxel Treated Patients | 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 \[100 pt -yrs\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Required Nintedanib Dose Reductions | From first drug administration until 28 days after the last drug administration, up to 586 days. | Percentage of patients who required nintedanib dose reductions. |
| Number of Patients Who Discontinued Study Drug Permanently Due to Adverse Events | From first drug administration until last drug administration, up to 558 days. | Number of patients who discontinued study drug permanently due to adverse events. |
Countries
India
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 5 |
| 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. | 9 |
| 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. | 1 |
| 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. | 3 |
| 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. | 1 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Change to other anti-cancer therapy | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 0 | 3 | 0 | 0 | 0 |
| Overall Study | Other than listed | 1 | 2 | 1 | 0 | 0 | 0 |
| Overall Study | Progression of disease | 4 | 3 | 4 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Nintedanib and Docetaxel: Group A | Nintedanib and Docetaxel: Group B | Nintedanib and Docetaxel: Group C | Single Agent Docetaxel: Group I | Single Agent Docetaxel: Group II | Single Agent Docetaxel: Group III | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 59.7 Years STANDARD_DEVIATION 5.8 | 59.8 Years STANDARD_DEVIATION 9.2 | 57.0 Years STANDARD_DEVIATION 12.1 | 39.0 Years | 61.7 Years STANDARD_DEVIATION 11.9 | 56.0 Years | 58.2 Years STANDARD_DEVIATION 9.6 |
| Race and Ethnicity Not Collected | — | — | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 7 Participants |
| Sex: Female, Male Male | 7 Participants | 2 Participants | 8 Participants | 1 Participants | 2 Participants | 1 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 23 |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 9 / 23 |
Outcome results
Primary
Incidence of All Adverse Drug Reactions (ADRs) in Nintedanib and Docetaxel Treated Patients
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 \[100 pt -yrs\].
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nintedanib and Docetaxel | Incidence of All Adverse Drug Reactions (ADRs) in Nintedanib and Docetaxel Treated Patients | 17.9 Patients per 100 patient years |
Primary
Incidence Rate of All Serious Adverse Events (SAEs) in Nintedanib and Docetaxel Treated Patients
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 \[100 pt -yrs\].
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nintedanib and Docetaxel | Incidence Rate of All Serious Adverse Events (SAEs) in Nintedanib and Docetaxel Treated Patients | 25.3 Patients per 100 patient years |
Secondary
Number of Patients Who Discontinued Study Drug Permanently Due to Adverse Events
Number of patients who discontinued study drug permanently due to adverse events.
Time frame: From first drug administration until last drug administration, up to 558 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nintedanib and Docetaxel | Number of Patients Who Discontinued Study Drug Permanently Due to Adverse Events | 2 Participants |
Secondary
Percentage of Patients Who Required Nintedanib Dose Reductions
Percentage of patients who required nintedanib dose reductions.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nintedanib and Docetaxel | Percentage of Patients Who Required Nintedanib Dose Reductions | 4.3 Percentage of Participants |