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Randomized, open label phase II study of brigatinib, carboplatin plus pemetrexed and brigatinib for chemotherapy-naive patients with ALK-rearranged non-squamous non-small cell lung cancer (WJOG14720L)

WJOG 14720L

Hirotsugu Kenmotsu

Shizuoka Cancer Center

1007 Shimonagakubo, Nagaizumi-cho, Suntou-gun, Shizuoka 411-8777, Japan

h.kenmotsu@scchr.jp

Kazushige Wakuda

Shizuoka Cancer Center

1007 Shimonagakubo, Nagaizumi-cho, Suntou-gun, Shizuoka 411-8777, Japan

+81-55-989-5222

k.wakuda@scchr.jp

Recruiting

Nov. 22, 2021

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1. Written informed consent obtained from the patient
2. Aged at least 20 years at the time of informed consent
3. Histologically or cytologically confirmed non-squamous non-small cell lung cancer
4. Confirmed ALK rearrangement by companion diagnostics
5. Stage IIIB, stage IIIC, stage IV, or postoperative relapse for which definitive radiotherapy is impossible
6. At least 1 measurable lesion based on RECIST v1.1
7. No symptomatic brain metastases
8. No symptomatic superior vena cava syndrome
9. No spinal cord compression
10. Patients with non-squamous non-small cell lung cancer previously untreated with chemotherapy
11. The specified time period has elapsed since the treatment defined in protocol
12. ECOG PS 0-1
13. Adequate organ function

1. Presence of active double cancers
2. Presence of active systemic infection or topical infection requiring surgical treatment
3. Presence of active hepatitis B or C
4. Pregnancy or Lactation in women
5. Men who do not intend to use contraception
6. Presence of symptomatic cerebrovascular diseases or past history of these within 1 year
7. Nausea, vomiting, or absorption impediments causing difficulty with administration of the trial drug
8. Presence of congestive heart failure and unstable angina or past history of myocardial infarction within 1 year
9. History of interstitial lung disease, drug-induced interstitial lung disease, and radiation pneumonitis requiring steroid treatment
10. Presence of psychiatric disorder or mental symptoms
11. Calculated based on prednisone, requiring continuous full-body administration of high-dosage steroids over 10 mg/day or currently using other immunosuppressant drugs
12. History of hypersensitivity to brigatinib, carboplatin, pemetrexed and any excipients of these drugs
13. Other patients determined unfit by an attending physician will also be excluded.

Both

Untreated ALK-rearranged non-squamous non-small cell lung cancer

The treatment of this study is followed
Group A
Brigatinib at a dose of 180mg once daily (with a 7-day lead-in period at 90mg)

Group B
Brigatinib at a dose of 180mg once daily (with a 7-day lead-in period at 90mg) combined with carboplatin area under the curve 5 and pemetrexed 500 mg/m2 in a 3-week cycle for up to four cycles, followed by concurrent brigatinib and pemetrexed maintenance

Progression free survival

Objective response rate, Overall survival, proportion of adverse events, evaluation of tumor-derived DNA with gene alteration from plasma specimens

+81-55-989-5222

Oct. 04, 2021

No

none