CompletedNot Applicable

Real-World Effectiveness of Afatinib (Gilotrif) Following Immunotherapy in the Treatment of Metastatic, Squamous Cell Carcinoma of the Lung: A Multi-Site Retrospective Chart Review Study in the U.S.

United States110 participantsStarted 2020-10-15

Plain-language summary

Characteristics of patients with Neuregulin-1 (NRG1) gene fusion-positive solid tumors treated with afatinib, and characteristics of those treated with another systemic therapy.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults, 18 years of age or older, at the time of diagnosis with any solid tumor. * Confirmed NRG1 gene fusion in any solid tumor. * Initiated afatinib or other systemic therapy (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01/01/2017 through 03/31/2020. * Followed up for ≥3 months after initiation of afatinib or other systemic therapy (unless deceased prior to 3 months of follow-up). Exclusion Criteria: \- Treatment with any Tyrosine kinase inhibitor (TKI)/ErbB-directed therapy other than afatinib

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Objective Response Rate (ORR): Based on Charted/Physician-reported Disease Response

Timeframe: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.

Objective Response Rate (ORR): Based on Lesion Measurements and RECIST v1.1 Criteria

Timeframe: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.

Duration of Objective Response (DOR)

Timeframe: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.

Duration of Clinical Benefit (DOCB)

Timeframe: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.

Progression Free Survival (PFS)

Timeframe: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.

Trial details

NCT IDNCT04750824

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-12-20

Results submitted2022-12-19

View on ClinicalTrials.gov More Non-squamous, Non-Small Cell Lung Cancer trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Objective Response Rate (ORR): Based on Charted/Physician-reported Disease Response

Timeframe: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.

Objective Response Rate (ORR): Based on Lesion Measurements and RECIST v1.1 Criteria

Timeframe: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.

Duration of Objective Response (DOR)

Timeframe: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.

Duration of Clinical Benefit (DOCB)

Timeframe: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.

Progression Free Survival (PFS)

Timeframe: From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.