Lorlatinib as Neoadjuvant Treatment in Stage IB-IIIB ALK-rearranged Non-Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University People's Hospital
About this trial
This project was designed To explore the pathological complete response (pCR) of lorlatinib as neoadjuvant treatment. Twenty-five patients will be involved in this study.
These patients will receive lorlatinib neoadjuvant therapy for 6-8 weeks (determined by clinicians' decision based on clinical practice) and then underwent surgery.
Previous small-sample clinical studies on ALK inhibitors as neoadjuvant therapy in resectable NSCLC have shown promising outcomes including MPR and pCR, supporting the potential of ALK TKIs in this setting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years
Imaging confirmed, resectable stage IB, II, IIIA or selected IIIB (including T4N2，per AJCC 8th edition)
Histologically/cytologically confirmed lung adenocarcinoma
Documented ALK-rearrangement mutation positive (assessed by a local laboratory)
Disqualifiers
Mixed squamous cell carcinoma, large cell carcinoma, small cell lung cancer.
Prior treatment with any systemic anti-cancer therapy for locally advanced NSCLC
Non-resectable stage IB, II, IIIA or selected IIIB NSCLC evaluated by thoracic surgeons.
Unable to tolerate curative surgery per anaesthesiologist evaluation.History of organ transplant.
Trial design
Design model
Single group
Treatments tested in this trial
Lorlatinib 100 mg
DrugEligible patients will be registered to receive oral lorlatinib 100mg qd for 6-8 weeks each during the neoadjuvant therapy phase
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Lorlatinib as Neoadjuvant TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pathologic Complete Response (pCR) Rate
Pathologic complete response (pCR) rate is defined as the percentage of participants with no residual viable tumor in lung primary or lymph nodes as evaluated by systematic pathological review of surgical specimens.
Time frame
Within 1 month after surgerySecondary outcomes
1
Objective response rate
Preoperative radiological evaluation (as assessed by the investigator according to RECIST v1.1) of the number of complete or partial responses as a proportion of the population in the cohort.
Time frame
Within 1 month after surgery2
Major Pathologic Response (MPR) Rate
Major pathologic response (MPR) rate is defined as the percentage of participants with less than or equal to 10% of residual viable tumor in lung primary or lymph nodes as evaluated by systematic pathological review of surgical specimens. Viable tumors in situ carcinoma should not be included in MPR calculation.
Time frame
Within 1 month after surgery3
Rate of lymph node downstaging
It is defined as the proportion of patients who have completed the neoadjuvant lorlatinib treatment before surgery and have achieved a N stage downing of the tumor as confirmed by CT evaluation after 6 weeks in all patients who have completed the treatment
Time frame
within 3 days after the last CT scan before surgery perfomed4
The delay of operation
the proportion of patients who have unanticipated delays to surgery \>6 weeks after completion of neoadjuvant treatment
Time frame
The 3rd day of post-operationLocations
Sponsors and contacts
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Peking University People's Hospital
Lead sponsor
Hunan Cancer Hospital
Collaborator
Liaoning Cancer Hospital & Institute
Collaborator
Air Force Military Medical University, China
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Source ClinicalTrials.gov
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