Post Marketing Surveillance of Nintedanib in Indian Patients With Non-small Cell Lung Cancer (NSCLC) After First-line Therapy

An observational study of Non-small Cell Lung Cancer, run by Boehringer Ingelheim at 11 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-small Cell Lung Cancer
How many people: 28 participants
Where: 11 sitesIndia
Study dates: 28 Feb 2017to 24 Sep 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 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).

Who may be able to join

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.

Who cannot join

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 exclusion criteria apply.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

India11 sites

Zydus Hospitals and Healthcare Research Pvt. Ltd
Anand, 388001
Narayana Hrudyalaya
Bangalore, 560099
Manipal Hospitals
Bengaluru, 560017
HCG Hospital
Bengaluru, 560027
Sparsh Hospitals and Critical Care
Bhubaneswar, 751007
Action Cancer Hospital, Delhi
Delhi, 110063
Apollo Health City Hospital
Hyderabad, 500033
Yashoda Hospitals
Hyderabad, 500082
Chittaranjan National Cancer Institute
Kolkata, 700026
Rajiv Gandhi Cancer Institute and Research Centre
New Delhi, 110085
SRM Institute of Medical Science
Vadapalani, 600026

Other trials in India

About this study

Official title: An Active Surveillance to Monitor the Real World Safety in Indian Patients Prescribed Nintedanib for the Treatment of Locally Advanced, Metastatic or Locally Recurrent Non Small Cell Lung Cancer (NSCLC) of Adenocarcinoma Tumor Histology After First Line Chemotherapy

Conditions: Non-small Cell Lung Cancer
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03017885
Study group	Role	What they receive
Group A		Patients who started treatment with nintedanib \& docetaxel after 23rd January, 2017 and have discontinued the drug at the time of participation in the active surveillance.
Group B		Patients who started treatment with nintedanib \& docetaxel after 23rd January, 2017 and are continuing the drug at the time of participation in the active surveillance .
Group C		Patients who have been newly prescribed nintedanib \& docetaxel at the time of participation in the active surveillance.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Percentage of Patients Who Required Nintedanib Dose Reductions
Percentage of patients who required nintedanib dose reductions.
Measured: From first drug administration until 28 days after the last drug administration, up to 586 days.
Number of Patients Who Discontinued Study Drug Permanently Due to Adverse Events
Number of patients who discontinued study drug permanently due to adverse events.
Measured: From first drug administration until last drug administration, up to 558 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 201724 Sep 2022

First posted11 Jan 2017 (estimated)
Study start28 Feb 2017
Primary completion24 Sep 2022
Study completion24 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03017885
Sponsor's protocol ID: 1199-0272
Status last verified: Sep 2023
First submitted: 10 Jan 2017
Last updated: 25 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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Active, not recruitingPhase 2
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All Non-small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Active Surveillance to Monitor the Real World Safety in Indian Patients Prescribed Nintedanib for the Treatment of Locally Advanced, Metastatic or Locally Recurrent Non Small Cell Lung Cancer (NSCLC) of Adenocarcinoma Tumor Histology After First Line Chemotherapy
ClinicalTrials.gov ID: NCT03017885
Acronym / sponsor ID: 1199-0272
Conditions: Non-small Cell Lung Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 28 Feb 2017 (actual)
Primary completion: 24 Sep 2022 (actual)
Study completion: 24 Sep 2022 (actual)
First posted: 11 Jan 2017 (estimated)
Results: Posted 25 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Other
Number of arms: 3

Arm	Type	Receives
Group A	–	–Patients who started treatment with nintedanib \& docetaxel after 23rd January, 2017 and have discontinued the drug at the time of participation in the active surveillance.
Group B	–	–Patients who started treatment with nintedanib \& docetaxel after 23rd January, 2017 and are continuing the drug at the time of participation in the active surveillance .
Group C	–	–Patients who have been newly prescribed nintedanib \& docetaxel at the time of participation in the active surveillance.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 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).

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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 exclusion criteria apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Incidence of All Adverse Drug Reactions (ADRs) in Nintedanib and Docetaxel Treated Patients
Time frame: 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
Time frame: 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].

2 secondary outcomes

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.
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.

Results and safety

Results posted to the registry on 25 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nintedanib and Docetaxel: Group A	9	0
Nintedanib and Docetaxel: Group B	5	0
Nintedanib and Docetaxel: Group C	9	0
Single Agent Docetaxel: Group I	1	1
Single Agent Docetaxel: Group II	3	3
Single Agent Docetaxel: Group III	1	1

Primary outcome: Incidence of All Adverse Drug Reactions (ADRs) in Nintedanib and Docetaxel Treated Patients

Time frame: From first drug administration until 28 days after the last drug administration, up to 586 days.. Number (95% Confidence Interval). Unit: Patients per 100 patient years

Measure	Nintedanib and Docetaxel n = 23
Value	17.9 (2.2 to 64.7)

Population analysed: 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.

Primary outcome: Incidence Rate of All Serious Adverse Events (SAEs) in Nintedanib and Docetaxel Treated Patients

Time frame: From first drug administration until 28 days after the last drug administration, up to 586 days.. Number (95% Confidence Interval). Unit: Patients per 100 patient years

Measure	Nintedanib and Docetaxel n = 23
Value	25.3 (12.7 to 45.4)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Docetaxel and Nintedanib	9 of 23 (39.1%)	0 of 23 (0%)	9 of 23

Limitations and caveats (from the sponsor): Study enrolled lower number of patients than the planned sample size due to low recruitment at the selected sites. The study was real-world active surveillance hence no examinations were mandated. Information collected as per clinical practice was available which may not have been consistent across patients and study duration. The extent of retrospectively collected study data for patients in Group A and I were dependent on the information available in medical records at the time of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Related trials for Non-small Cell Lung Cancer

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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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NSCLC, Non-Small Cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Non-small Cell Lung Cancer, run by Boehringer Ingelheim at 11 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of All Adverse Drug Reactions (ADRs) in Nintedanib and Docetaxel Treated Patients (time frame: From first drug administration until 28 days after the last drug administration, up to 586 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03017885.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.