This is a Phase I, multicentre, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, PD, and PK of [111In]-FPI-2107 after pre-dose administration of FPI-2053 in Chinese participants with EGFR mutation-positive NSCLC.

Inclusion Criteria:

• Histologically or cytologically confirmed EGFR mutation positive NSCLC.
• Without any ongoing anti-cancer therapy or with stable ongoing anti-cancer therapy.
• At least one lesion that is present on 18F-FDG PET/CT scan during screening.
• ECOG performance status of 0 or 1.
• Anticipated life expectancy ≥ 12 weeks, in the opinion of the Investigator.
• Able to provide tumour tissue for analysis.

Exclusion Criteria:

• Confirmed radiographic disease progression or Investigator-assessed clinical disease progression within 28 days prior to the administration of [111In]-FPI-2107.
• Contraindications to or inability to perform the imaging procedures required in this study.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (≥ once per month).
• History of myocardial infarction or New York Heart Association Class II-IV congestive heart failure within 6 months of the administration of [111In]-FPI-2107, CTCAE Grade 2 or worse conduction defect or uncontrolled hypertension.
• Clinically relevant proteinuria, or daily urinary protein excretion > 500 mg).
• Any antibody-based therapy targeting EGFR and/or c-MET, or investigational agent within 28 days or 5 half-lives prior to the administration of [111In]-FPI-2107, whichever is shorter.
• Any systemic radiopharmaceutical within 28 days or 5 radioactive half-lives prior to the administration of [111In]-FPI-2107, whichever is shorter.
• Any anticipated need for switching of any concomitant anti-cancer therapy during the imaging period of the study.
• External beam radiation therapy within 28 days prior to the administration of [111In]-FPI-2107.

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.