Clinical trial NCT06376084: Osimertinib With Chemotherapy as First-line Therapy for EGFR Mutation-positive NSCLC
Official title: Osimertinib With Chemotherapy as First-line Therapy for Patients With Locally Advanced or Metastatic Epidermal Growth Factor Receptor (EGFR) Mutation-positive Non-Small Cell Lung Cancer (NSCLC): A Multicentre, Observational Study (FOREFRONT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Keywords: Osimertinib
Epidermal Growth Factor Receptor
NSCLC
Non-small cell lung cancer
Observational
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-04-19
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with locally advanced or metastatic, EGFR mutation-positive (Ex19del and/or 21 L858R) NSCLC who receive Osimertinib plus chemotherapy as the first-line therapy based on physician's medical assessment will be enrolled. Approximately 700 patients will be enrolled from about 60 sites in China.

Brief summary: To estimate parameters related to clinical outcomes in a real-world seeting, including investigator reported PFS and OS.

Detailed description: The objectives of this study are to assess the effectiveness and safety of Osimertinib combined with chemotherapy in a real-world setting in patients with locally advanced or metastatic, EGFR mutation-positive NSCLC.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Histologically or cytologically documented nonsquamous NSCLC. NSCLC of mixed histology is allowed.
* Stage IIIB or IIIC or Stage IV metastatic NSCLC or recurrent NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative surgery or definitive chemoradiation.
* EGFR sensitive mutation-positive (Ex19del and/or 21 L858R)
* WHO performance status of 0 to 2 at screening with no clinically significant deterioration in the previous 2 weeks.
* Patients who receive Osimertinib plus chemotherapy as first-line treatment based on physician's medical assessment are eligible (For patients who received prior chemotherapy alone/Osimertinib monotherapy/Osimertinib plus chemotherapy as first-line therapy ahead of enrolment, they are diseases progression-free at the time of enrolment and the duration of prior therapy ≤3 months).
* Patients with asymptomatic CNS metastases or patients who have completed definitive therapy, are not on steroids and have a stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids are allowed.
* Prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation/chemoradiation with or without regimens including immunotherapy, biologic therapies, investigational agents are permitted as long as treatment was completed at least 12 months prior to the development of recurrent disease.

Exclusion Criteria:

* Spinal cord compression and symptomatic brain metastases
* Past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD
* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, etc
* Any banned substance in label

Primary outcomes:
measure: Real-World Progression Free Survival (rwPFS)
timeFrame: Follow up approximately 36 months after last patient in
Secondary outcomes:
measure: Chemotherapy regimen
timeFrame: Follow up approximately 36 months after last patient in
measure: Duration of chemotherapy (induction and maintenance cycles)
timeFrame: Follow up approximately 36 months after last patient in
measure: Response rate
timeFrame: Follow up approximately 36 months after last patient in
measure: Duration of response
timeFrame: Follow up approximately 36 months after last patient in
measure: Overall survival (OS)
timeFrame: Follow up approximately 36 months after last patient in
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Research Site
Study officials:
affiliation: Shanghai Chest Hospital
name: Baohui HAN
role: PRINCIPAL_INVESTIGATOR
References: