Non Small Cell Lung Cancer (NSCLC)Phase 4NCT03853551

Osimertinib Study in Indian Patients

A Phase 4 study testing Osimertinib in people with Non Small Cell Lung Cancer (NSCLC), run by AstraZeneca at 7 sites in India.

Completed

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

Official record

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Trial summary

This is a prospective, single-arm, multicenter, phase-IV study investigating the safety of osimertinib in Indian adult patients. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Non Small Cell Lung Cancer (NSCLC)
What is being tested?: Osimertinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 7 sitesIndia
Study dates: 18 Apr 2019to 15 Apr 2020
Phase: Phase 4
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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient of either gender and ≥18 years of age
Patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an appropriate test, who have progressed on or after EGFR TKI therapy by an independent clinical judgment of treating physician based on locally approved prescribing information
Each patient must sign an informed consent form (ICF)

Who cannot join

Patient with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug.
Pregnant and/or lactating women
Patients participating in any current or future interventional trial will not be enrolled in the current study

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

India7 sites

Research Site
Hyderabad, 500034
Research Site
Hyderabad, 500096
Research Site
Kolkata, 700160
Research Site
Mumbai, 400012
Research Site
Mumbai, 400053
Research Site
New Dehli, 110029
Research Site
New Delhi, 110085

Other trials in India

About this study

Official title: A Prospective, Multicenter, Phase-IV Clinical Trial to Assess Safety of Osimertinib in Indian Adult Patients With Metastatic Epidermal Growth Factor Receptor (EGFR) T790M Mutation-positive Non-small Cell Lung Cancer (NSCLC).

This is a prospective, single-arm, multicenter, phase-IV study investigating the safety of osimertinib in Indian adult patients.

Read the detailed description

This is a prospective, single-arm, multicenter, phase-IV trial investigating the safety of osimertinib in Indian adult patients with locally advanced or metastatic EGFR-T790M mutation-positive NSCLC.

Prior to data collection, all patients must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements and sponsor policy.

Patients with metastatic EGFR T790M mutation-positive NSCLC, who are eligible to osimertinib treatment as per locally approved prescribing information and ratified by an independent clinical judgment of treating physician will be evaluated for the inclusion into the current phase-IV study based on eligibility criteria. EGFR T790M positivity on plasma or tissue biopsy on PCR-based platform will be considered appropriate test. EGFR T790M must be performed after progressive disease on last line of therapy (on or after EGFR TKI therapy). In order to enroll approximately 60 patients, it is expected that approximately 70 patients will be screened.

Conditions: Non Small Cell Lung Cancer (NSCLC)
Being tested: Osimertinib
Keywords: Non small cell lung cancer (NSCLC)
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.

OsimertinibDrug
Osimertinib is an oral, potent, selective, irreversible inhibitor of both epidermal growth factor receptor - Tyrosine kinase inhibitors (EGFR-TKI) sensitizing and resistance mutations in nonsmall cell lung cancer (NSCLC) with a significant selectivity margin over wild-type EGFR.

Study groups in NCT03853551
Study group	Role	What they receive
Single	Experimental	Single arm Receives: Drug: Osimertinib

What is being measured

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

Safety of Osimertinib
Number of Patients with treatment emergent Adverse Events
Measured: 5 months

Timeline

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

18 Apr 201915 Apr 2020

First posted25 Feb 2019
Study start18 Apr 2019
Primary completion15 Apr 2020
Study completion15 Apr 2020

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
More trials run by AstraZenecaThe 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03853551
Sponsor's protocol ID: D5161C00005
Status last verified: May 2021
First submitted: 20 Feb 2019
Last updated: 3 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Publications

Malik PS, Noronha V, Dabkara D, Maddu VK, Rajappa S, Limaye S, Batra U. Safety of osimertinib in adult patients with metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer: Results from a Phase IV study in India. Indian J Cancer. 2022 Mar;59(Supplement):S1-S10. doi: 10.4103/ijc.ijc_1374_21.
PubMed 35343187

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Phase-IV Clinical Trial to Assess Safety of Osimertinib in Indian Adult Patients With Metastatic Epidermal Growth Factor Receptor (EGFR) T790M Mutation-positive Non-small Cell Lung Cancer (NSCLC).
ClinicalTrials.gov ID: NCT03853551
Acronym / sponsor ID: D5161C00005
Conditions: Non Small Cell Lung Cancer (NSCLC)
Keywords: Non small cell lung cancer (NSCLC)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 18 Apr 2019 (actual)
Primary completion: 15 Apr 2020 (actual)
Study completion: 15 Apr 2020 (actual)
First posted: 25 Feb 2019 (actual)
Results: Posted 3 Jun 2021

Clinical summary

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

This is a prospective, single-arm, multicenter, phase-IV study investigating the safety of osimertinib in Indian adult patients.

Detailed description

This is a prospective, single-arm, multicenter, phase-IV trial investigating the safety of osimertinib in Indian adult patients with locally advanced or metastatic EGFR-T790M mutation-positive NSCLC.

Prior to data collection, all patients must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements and sponsor policy.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single	Experimental	Drug: OsimertinibSingle arm

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patient of either gender and ≥18 years of age
Patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an appropriate test, who have progressed on or after EGFR TKI therapy by an independent clinical judgment of treating physician based on locally approved prescribing information
Each patient must sign an informed consent form (ICF)

Key exclusion criteria (3 listed)

Patient with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug.
Pregnant and/or lactating women
Patients participating in any current or future interventional trial will not be enrolled in the current study

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

Interventions

Intervention	Type	Arms
OsimertinibOsimertinib is an oral, potent, selective, irreversible inhibitor of both epidermal growth factor receptor - Tyrosine kinase inhibitors (EGFR-TKI) sensitizing and resistance mutations in nonsmall cell lung cancer (NSCLC) with a significant selectivity margin over wild-type EGFR.	Drug	Single

Primary outcome

Safety of Osimertinib
Time frame: 5 months
Number of Patients with treatment emergent Adverse Events

Results and safety

Results posted to the registry on 3 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm	60	51

Primary outcome: Safety of Osimertinib

Time frame: 5 months. Count of participants. Unit: Participants

Measure	Single Arm n = 60
Value	60

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Arm	7 of 60 (11.7%)	51 of 60 (85%)	3 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35343187Malik PS, Noronha V, Dabkara D, Maddu VK, Rajappa S, Limaye S, Batra U. Safety of osimertinib in adult patients with metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer: Results from a Phase IV study in India. Indian J Cancer. 2022 Mar;59(Supplement):S1-S10. doi: 10.4103/ijc.ijc_1374_21.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

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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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Osimertinib in people with Non Small Cell Lung Cancer (NSCLC), run by AstraZeneca at 7 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 3 inclusion and 3 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 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2021). 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?

Safety of Osimertinib (time frame: 5 months). 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 NCT03853551, which also lists 1 linked publication.

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 3 Jun 2021.