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. 2022 Jan 7;2022(1):CD013453. doi: 10.1002/14651858.CD013453.pub2

NCT04009317.

Study name Study of TQ‐B3139 versus crizotinib in the first line treatment of subjects with anaplastic lymphoma kinase (ALK) positive non‐small cell lung cancer (NSCLC)
Methods Study design: randomised controlled trial
Study grouping: parallel group
Participants Baseline characteristics
TQ‐B3139 tablet 600 mg administered orally, twice daily in 28‐day cycle.

  • Median age (range):

  • Female %:

  • Ethnicity Asian %:

  • ECOG 0 to 1 %:

  • Never smoked %:

  • Stage of disease IV at entry %:

  • Adenocarcinoma %:

  • Brain metastases at entry %:

  • Previous chemotherapy %:

  • Previous targeted therapy %:


Crizotinib tablet 250 mg administered orally, twice daily in 28‐day cycle.

  • Median age (range):

  • Female %:

  • Ethnicity Asian %:

  • ECOG 0 to 1 %:

  • Never smoked %:

  • Stage of disease IV at entry %:

  • Adenocarcinoma %:

  • Brain metastases at entry %:

  • Previous chemotherapy %:

  • Previous targeted therapy %:


Inclusion criteria

  • 18 and 75 years

  • ECOG PS score of 0 to 1.3. Life expectancy ≥ 12 weeks

  • Histologically or cytologically confirmed advanced or metastatic NSCLC with ALK‐positive

  • Has not received ALK TKI

  • Has received 1 chemotherapy regimen for stage IIIB‐IV NSCLC

  • At least 1 measurable lesion

  • Adequate organ system function

  • Understood and signed an informed consent form


Exclusion criteria

  • Has diagnosed and/or treated additional malignancy within 5 years prior to randomisation. Exceptions include cured cancer carcinoma in situ of the cervix, intramucosal carcinoma of gastrointestinal tract, breast and melanoma skin cancers, and superficial bladder tumours.

  • Hypersensitivity to TQ‐B3139 or crizotinib

  • Has received any cancer therapy within 4 weeks or 5 times of t1/2

  • Has received any major surgery within 4 weeks

  • Has received any radiotherapy or minor surgery aimed to cure cancer within 2 weeks

  • Acute toxicity that is ≥ Grade 2 caused by previous cancer therapy

  • Has active viral, bacterial, and fungal infections within 2 weeks before the first dose

  • Has serious cardiovascular disease within 3 months before the first dose

  • Has currently uncontrollable congestive heart failure

  • Has continuous arrhythmia ≥ Grade 2, uncontrollable atrial fibrillation, or QTc interval > 480 ms

  • Has interstitial fibrosis or interstitial lung disease ≥ Grade 3

  • Brain metastases with symptom

  • Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus (HBV) DNA positive (≥ upper limit of normal (ULN)); hepatitis C virus (HCV) antibody and HCV‐ribonucleic acid (RNA) positive (≥ ULN); HIV positive or ≥ HIV ULN

  • Has multiple factors affecting oral medication

  • Has received a strong CYP3A inhibitor within 7 days before the first dose

  • Has received a strong CYP3A inducer

  • Breastfeeding or pregnant women; men unwilling to use adequate contraceptive measures during the study

  • According to the judgement of the researchers, there are other factors that make the patient unsuitable for the study.
Interventions Intervention characteristics
TQ‐B3139 tablet 600 mg administered orally, twice daily, continuously in 28‐day cycle.

  • Type: TKI


Crizotinib tablet 250 mg administered orally, twice daily, continuously in 28‐day cycle.

  • Type: TKI
Outcomes Progression‐free survival (PFS) [ Time Frame: up to 36 months ]
Objective response rate (ORR) [ Time Frame: up to 36 months ]
Disease control rate (DCR) [ Time Frame: up to 36 months ]
Overall survival (OS) [ Time Frame: up to 36 months ]
Starting date August 2019
Contact information Li Zhang, Doctor; zhangli@sysucc.org.cn
Notes clinicaltrials.gov/ct2/show/NCT04009317