Clinical trial • Phase IV • Oncology

LORLATINIB for Non-small cell lung cancer | Lung cancer

Phase IV trial of LORLATINIB for Non-small cell lung cancer | Lung cancer. open-label. 183 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer | Lung cancer
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
11-12-2023
First CTIS Authorization Date
17-01-2024

Trial design

open-label Phase IV trial across 2 sites in Spain, France.

Open Label
Yes
Target Sample Size
183

Eligibility

Recruits 183 Vulnerable population not selected. Participants must be capable of giving signed informed consent as described in Appendix 1, Section 10.1.3. No assent procedures or enrolment of minors are indicated in the available documentation..

Pregnancy Exclusion
1. Female participants who are pregnant or breastfeeding.
Vulnerable Population
Vulnerable population not selected. Participants must be capable of giving signed informed consent as described in Appendix 1, Section 10.1.3. No assent procedures or enrolment of minors are indicated in the available documentation.

Inclusion criteria

  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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)."}
  • {"criterion_text":"- 3. Adequate organ function as defined by the following criteria: •\tHepatic 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); •\tBone 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; •\tRenal function: Serum creatinine ≤2.0 × ULN."}
  • {"criterion_text":"- 4. Participants who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures."}
  • {"criterion_text":"- 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

  • {"criterion_text":"- 1. Female participants who are pregnant or breastfeeding."}
  • {"criterion_text":"- 2. Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- AEs leading to permanent discontinuation of lorlatinib","definition_or_measurement_approach":""}
  • {"endpoint_text":"- All SAEs","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
183
Recruitment Window Months
52
Consent Approach
Participants must be capable of giving signed informed consent as described in Appendix 1, Section 10.1.3 of the protocol. Public subject information and informed consent form documents are available in Spanish and French (public ICF documents listed for ES and FR). No assent for minors is described and participants must be capable of providing consent.

Geography

Total Number Of Sites
2
Total Number Of Participants
17

Spain

Earliest CTIS Part Ii Submission Date
20-11-2023
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
869
Number Of Sites
1
Number Of Participants
7

Sites

Site Name
Vall D'hebron Institut De Recerca
Department Name
Servicio de Oncología
Principal Investigator Name
Enriqueta Felip
Principal Investigator Email
efelip@vhio.net
Contact Person Name
Enriqueta Felip
Contact Person Email
efelip@vhio.net
Number Of Participants
7

France

Earliest CTIS Part Ii Submission Date
20-11-2023
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
869
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Institut Gustave Roussy
Department Name
Departement d'innovation Therapeutique des Essais Precoces
Principal Investigator Name
Benjamin Besse
Principal Investigator Email
benjamin.besse@gustaveroussy.fr
Contact Person Name
Benjamin Besse
Number Of Participants
10

Sponsor

Primary sponsor

Full Name
Pfizer Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Syneos Health
Responsibilities
sponsorDuties codes: 1,5

Third parties

  • {"country":"United Kingdom","full_name":"Syneos Health","duties_or_roles":"codes: 1,5","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Global translation services","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
LORLATINIB
Active Substance
LORLATINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Maximum Dose
100 mg

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