Osimertinib With Chemotherapy as First-line Therapy for EGFR Mutation-positive NSCLC

Neoplasms Clinical Trial

— FOREFRONT  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376084
• Other study ID #: D5161R00055
• Status: Not yet recruiting
• Start date: July 24, 2024
• Est. completion date: February 28, 2028

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: February 28, 2028
• Est. primary completion date: February 28, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchial Neoplasms
• Carcinoma
• Carcinoma, Bronchogenic
• Carcinoma, Non-Small-Cell Lung
• Lung Diseases
• Lung Neoplasms
• Neoplasms
• Neoplasms by Site
• Respiratory Tract Diseases
• Respiratory Tract Neoplasms
• Thoracic Neoplasms

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-World Progression Free Survival (rwPFS)	rwPFS is defined as the time from the date of first-line initiation until disease progression or death by investigator report as recorded in the CRF	Follow up approximately 36 months after last patient in
Secondary	Chemotherapy regimen	Chemotherapy information i.e. dose, number of induction chemotherapy cycles and duration of chemotherapy maintenance, any dose changes and reasons for these changes and date of last administration will also be recorded.	Follow up approximately 36 months after last patient in
Secondary	Duration of chemotherapy (induction and maintenance cycles)	Duration of first-line Osimertinib plus chemotherapy, and duration of initial therapy prior to first-line Osimertinib plus chemotherapy (i.e., prior Osimertinib only, prior chemotherapy only).	Follow up approximately 36 months after last patient in
Secondary	Response rate	Response rate (RR) is defined as the percentage of patients with the best response of "responding" by investigator report as recorded in CRF. Patients who discontinue treatment without progression, receive a subsequent therapy, and then respond will not be included as responders in the RR calculation.	Follow up approximately 36 months after last patient in
Secondary	Duration of response	DoR: is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression. The end of response should coincide with the date of progression or death from any cause used for the PFS endpoint. The time of the initial response will be defined as the latest of the dates contributing toward the first visit response. If a patient does not progress following a response, then his/her duration of response will use the PFS censoring time as the end point for their DoR calculation.	Follow up approximately 36 months after last patient in
Secondary	Overall survival (OS)	OS is defined as the time from the first-line initiation until death due to any cause regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy.	Follow up approximately 36 months after last patient in