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A Study Comparing Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer

ConditionsALK Fusion Protein ExpressionAdjuvant TherapyNon-Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-73
SponsorSichuan University

About this trial

This randomized, active-controlled, multicenter, open-label, Phase II study is designed to evaluate the efficacy and safety of ensatinib compared with Platinum-Based Chemotherapy as adjuvant treatment in ALK fusion positive II-IIIA stage non-small cell lung cancer after surgical resection

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Surgical resection of histologically confirmed Stage IIA to IIIA NSCLC with negative margins, ,within 10 weeks after the operation

Documented ALK-positive disease according to FISH , Ventana IHC ,RT-PCR or NGS

Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1

At least 3-months life expectancy

Disqualifiers

More than 10 weeks before surgery Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ

Use of other investigational drug within 4 weeks prior to the first dose of Ensartinib

Prior stem cell or organ transplant

severe cardiovascular disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ensatinib

    Drug

    225 mg administered once daily orally for two years.

  • chemotherapy

    Drug

    Pemetrexed : Participants will receive 500 mg/m\^2, day 1 , Q21D , until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first. Cisplatin :Participants will receive 75 mg/m\^2, day 1 , 21 days/cycle, Q21D , until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first. Paclitaxel: Participants will receive 175 mg/ m\^2, day 1 , 21 days/cycle, Q21D , until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first. carboplatin AUC= 5 mg/ mL/min, intravenously guttae, day 1 ,Q21D ，until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: EnsatinibExperimental treatment 1 intervention
Group B: Platinum-Based ChemotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Disease free survival (DFS)

Time frame
From date of randomization until date of the first observation of tumor recurrence, metastasis (based on imaging ) or death, up to approximately 5 years.

Secondary outcomes

1

DFS at 2 years

Time frame
Assessed at 2 years
2

DFS at 3 years

Time frame
Assessed at 3 years
3

Overall survival (OS)

Time frame
The time from the date of randomization to death from any cause, up to approximately 7 years
4

OS rate at 5 years

Time frame
Assessed at 5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan University

Lead sponsor

Betta Pharmaceuticals Co., Ltd.

Collaborator

Source ClinicalTrials.gov

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