Active — Not RecruitingPhase 4

Lorlatinib Continuation Study

United States, China76 participantsStarted 2021-12-28

Plain-language summary

The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer sponsored lorlatinib parent studies that will be closed. Additional follow-up safety data collection will permit further characterization of the safety profile of lorlatinib in participants continuing to receive study intervention

Who can participate

Age range18 Years

SexALL

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

Inclusion Criteria: 1 - Any participant who is receiving study treatment and deriving clinical benefit (as determined by the Principal Investigator) in a Pfizer-sponsored Lorlatinib Parent Study. 2- Participants must agree to follow the reproductive criteria. 3- Adequate Bone Marrow, Liver, Renal, Pancreatic Function Exclusion Criteria: 1 - Female participants who are pregnant or breastfeeding. 2- Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.

What they're measuring

Number of participants with adverse events leading to permanent discontinuation of study intervention

Timeframe: Baseline up to approximately 5 years

Number of serious adverse events reported for all participants

Timeframe: Baseline up to approximately 5 years

Trial details

NCT IDNCT05144997

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-28

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