Phase II study of carboplatin+nab-paclitaxel+tremelimumab+durvalumab combination therapy for TTF-1 negative advanced non-squamous non-small cell lung cancer (WJOG17223L, TURNING trial)
WJOG17223L, TURNING trial
Tachihara Motoko
Kobe university hospital
7-5-2 kusunoki, Chuo-ku, Kobe, Hyogo
+81-783825668
mt0318@med.kobe-u.ac.jp
Tachihara Motoko
Kobe university hospital
7-5-2 kusunoki, Chuo-ku, Kobe, Hyogo
+81-783825668
mt0318@med.kobe-u.ac.jp
Recruiting
Jan. 15, 2025
57
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
treatment purpose
1) The patients written consent will be obtained
2) Patients must be at least 18 years
3) Histologically diagnosed as nonsquamous NSCLC
4) Immunohistochemical staining is negative for TTF1
5) EGFR mutation test and ALK fusion gene result is negative
6) Non radiation curable stage 3, 4 Postoperative recurrence
7) The patient has measurable disease.
8) No symptomatic brain metastases
9) No symptoms of superior vena cava syndrome
10) No spinal cord compression disease
11) No drug therapy for non squamous NSCLC
Cases in which drugs that specifically target the checkpoint pathway
12) At the time of enrollment, the specified period of time since completion of the previous treatments or procedures
13) ECOG performance status is 0,1
14) Patients must be free from severe disorders of major organs
15) Expected to survive at least 3 months
16) Weighs at least 30kg.
1) Patient has multiple active cancers.
Duplication of carcinoma in situ or intramucosal carcinoma equivalent that is considered curable by local treatment shall not be included in the definition of active duplication of carcinoma.
2) Has a local infection or active systemic infection requiring treatment
3) Has active hepatitis B, hepatitis C infection
4) Active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
5)Interstitial lung disease is evident on computed tomography (CT).
6) Patients with a history of autoimmune disease complicated with active autoimmune disease or requiring steroid therapy or immunosuppressive drugs.
7) Patients with non autoimmune diseases requiring continuous systemic administration (oral or intravenous) of steroids at doses 10 mg/day prednisolone equivalent or patients who used immunosuppressive drugs within 14 days prior to enrollment
8) Patients with symptomatic congestive heart failure, unstable angina, or a history of myocardial infarction within the last year prior to enrollment
9) Patients with the following arrhythmias on electrocardiogram (ECG) and considered clinically serious
10) Patients with gastrointestinal perforation, fistula, or diverticulitis, or with a history of such perforation, fistula, or diverticulitis within 1 year.
11) Patients with uncontrolled peptic ulcer
12) Patients with diabetes uncontrolled by appropriate treatment.
13) Patients with a history of immunotherapy, including durvalumab, tremelimumab, and immuno-antibody therapy, for malignant tumors
14) Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non cancer related conditions (ex. hormone replacement therapy) is acceptable.
15) Patients with a history of severe drug allergy or hypersensitivity to any ingredient or additive of carboplatin or paclitaxel.
16) Patients with Grade 2 or higher peripheral neuropathy
17) Pregnant women, lactating women, women who may be currently pregnant, or patients
18) Patients with clinically problematic psychiatric disorders that would preclude enrollment in the study.
19) Patients who may become a blood donor during the study and within 90 days from the last administration.
20) Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow up period of an interventional study.
21) Any unresolved toxicity NCI CTCAE Grade 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
22) History of allogenic organ transplantation.
23) History of leptomeningeal carcinomatosis
24) History of active primary immunodeficiency
25) Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
26) Other patients whose uncontrolled intercurrent illness, including but not limited to above, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent, or are deemed inappropriate by the study investigator or others.
