Induction Lorlatinib in Stage III Non-small Cell Lung Cancer

Last updated: May 20, 2023
Sponsor: Guangdong Provincial People's Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Surgery

Treatment

Lorlatinib

Clinical Study ID

NCT05740943
LORIN
  • Ages 18-75
  • All Genders

Study Summary

A prospective, single-arm, open-label phase 2 study that evaluates the efficacy and safety of induction Lorlatinib in stage III non-small cell lung cancer and explores the clinical feasibility of dynamic ctDNA and multidisciplinary assessment in guiding local treatments.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age :18 Years to 75 Years;
  • ECOG physical score 0-2 points; expected survival time ≥ 1 year;
  • Pathologically confirmed diagnosis with Stage III NSCLC which harbored ALK fusiondetected by next generation sequencing (NGS) or immunohistochemistry (IHC) with orwithout FISH. Suspected N2 (station 2/4/7) for stage III disease should be confirmedby either mediastinoscopy or EBUS.
  • At least one measurable target lesion according to the RECIST 1.1 standard;
  • The main organ function meets the following criteria: 1) blood routine: absolute valueof neutrophils ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80 g / L; 2)blood biochemistry: total bilirubin ≤ 1.5 times the upper limit of normal value,aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit ofnormal value (if liver metastasis, ≤ upper limit of normal value 5 times), serumcreatinine ≤ 1.5 times the upper limit of normal;
  • Subjects voluntarily joined the study and signed informed consent, with goodcompliance to follow-up.

Exclusion

Exclusion Criteria:

  • Stage I, stage II and metastatic stage IV NSCLC;
  • Histologically confirmed small cell lung cancer (including lung cancer mixed withsmall cell lung cancer and non-small cell lung cancer);
  • Patients who have previously used any other anti-tumor drugs or receivedsurgery/radiotherapy;
  • Patients with any underlying disease that investigators consider it may affectpatient's prognosis including sever cardiovascular, pulmonary disease or seriousinfections.
  • Clinically obvious gastrointestinal abnormalities, which may affect the intake,transport or absorption of drugs (such as inability to swallow, chronic diarrhea,intestinal obstruction, etc.), or patients with total gastrectomy;
  • Pregnant or lactating women; those who have fertility are unwilling or unable to takeeffective contraceptive measures;
  • Patients with low compliance or willingness to take the drugs and surveillance.

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: Lorlatinib
Phase: 2
Study Start date:
March 15, 2023
Estimated Completion Date:
December 31, 2026

Study Description

Simon two-stage was applied to estimate the required sample size for the study. Overall an estimated 43 patients were required and at least 12 patients achieved pathological complete response would be deemed as positive result. Patients will be provided 3 cycles induction Lorlatinib 100mg and then assessed whether patients would be eligible for radical surgery or local radiotherapy through multidisciplinary evaluation. After local intervention, patients could choose consolidation treatment of Lorlatinib for up to 2 years or adjuvant doublet chemotherapy for up to 4 cycles. Dynamic blood samples will be collected before and after induction Lorlatinib as well as consolidation treatment. The primary endpoints is pCR for patients who received radical surgery.

Connect with a study center

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.