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 range18 Years

SexALL

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

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.

Time on Treatment (TOT)

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 range18 Years

SexALL

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.

Time on Treatment (TOT)

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.