OGIK2102

Phase 2

Recruiting

• Conditions: TTF-1 negative treatment-naive advanced non-squamous non-small cell lung cancer; NSCLC, advanced, driver oncogene negative, TTF-1 negative; D002289

• Registration Number: JPRN-jRCTs071220008
• Lead Sponsor: Okamoto Isamu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

(1) Cytologically or histologically confirmed non-squamous non-small cell lung cancer.
(2) Clinical stage III without indication of definitive thoracic radiotherapy, stage IV, postoperative recurrent disease, or recurrence after radiation therapy.
(3) No prior systemic chemotherapy.
(4) No prior drug therapy that specifically target the T cell co-stimulation or checkpoint pathway, such as anti-PD-1 antibody, anti-PD-L1 antibody, and anti-CTLA-4 antibody.
(5) Has a lesion on imaging. (With or without measurable lesion)
(6) Over 20 years old.
(7) Performance status 0 or 1.
(8) No driver-oncogene alterations.
(9) TTF-1 is negative for IHC
(10) No symptomatic brain metastasis.
(11) If the following prior treatment is performed before registration, the specified period has passed since the end of the treatment.
(i) No prior stereotactic irradiation and Gamma-knife for central nervous system metastases within one day.
(ii) No prior whole-brain irradiation within 7 days.
(iii) No prior palliative radiation therapy for non-central nervous system metastases within 7 days.
(iv) No prior pleural drainage within 7 days.
(v) No prior surgery with general anesthesia within 14 days.
(12) Adequate organ function.
(i) Neutrophil count >= 1,500/mm3
(ii) Hemoglobin >= 9.0 g/dL
(iii) Platelet count >= 100,000/mm3
(iv) AST, ALT =<100 IU/L(cases with liver metastases AST, ALT =<200 IU/L)
(v) T.bil =< 1.5 mg/dL
(vi) Serum creatinine =< 1.5 mg/dL
(13) Written informed consent.

Exclusion Criteria

(1) Synchronous double or multiple cancer or metachronous double or multiple cancer within 2 years.
(2) Infectious disease requiring systemic treatment.
(3) Active hepatitis B.
(4) Findings suggestive of interstitial lung disease or pulmonary fibrosis on the chest computed tomography.
(5) Active autoimmune disease.
(6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
(7) Has serious complications.
(i) Frequent transient ischemic attacks.
(ii) Symptomatic congestive heart failure, unstable angina, or a history of myocardial infarction within a year.
(iii) Clinically serious arrhythmia on the electrocardiogram.
(iv) Gastrointestinal perforation, fistula, diverticulitis within a year.
(v) Uncontrollable peptic ulcer.
etc.
(8) Grade 2 or higher peripheral neuropathy.
(9) Hypersensitivity to the ingredients / additives of carboplatin, nab-paclitaxel, and atezolizumab.
(10) Psychological disorder difficult to participate in this clinical study.
(11) During pregnancy, within 28 days of postparturition, or during lactation.
(12) Other cases that the doctor considers inappropriate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified