Lorlatinib Continuation Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

2 Aug 2022 → ongoing

Decision date (initial)

2024-02-16

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Pfizer Inc.

External identifiers

EU CT number

2023-508952-21-00

EudraCT number

2021-005569-42

ClinicalTrials.gov

NCT05144997

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety

To monitor the safety and tolerability of study intervention(s)

Secondary objectives 1

1. N/A

Conditions and MedDRA coding

Lung cancer

Regulatory references

Plan to share IPD

Yes

IPD plan description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 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. 2. Participants must agree to follow the reproductive criteria as outlined in Appendix 3 (Section 10.3.1 for males and Section 10.3.2 for females).
3. 3. Adequate organ function as defined by the following criteria: • Hepatic function: Serum AST and serum ALT ≤2.5 × ULN, or AST and ALT ≤5 × ULN if liver function abnormalities were due to underlying malignancy; total serum bilirubin ≤1.5 × ULN (except participants with documented Gilbert’s syndrome); • Bone marrow function: absolute neutrophil count ≥1000/μL (1.0 x 109 /L or 1000/mm3), platelets ≥50,000/μL (50 x 109 /L or 50000/mm3); hemoglobin ≥8.0 g/dL; • Renal function: Serum creatinine ≤2.0 × ULN.
4. 4. Participants who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures.
5. 5. Capable of giving signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion criteria 2

1. 1. Female participants who are pregnant or breastfeeding.
2. 2. Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. AEs leading to permanent discontinuation of lorlatinib
2. All SAEs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

66 Hudson Boulevard East

City

New York

Postcode

10001-2189

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Dana Kennedy

Public contact point

Organisation

Pfizer Inc.

Contact name

Dana Kennedy

Third parties 2

Locations

2 EU/EEA countries · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications