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Phase II trial of carboplatin + nab-paclitaxel + atezolizumab combination therapy for TTF-1 negative advanced non-squamous non-small cell lung cancer (LOGIK2102)

LOGIK2102 (F1NE TUNE)

52

A total of 52 patients with TTF-1 negative advanced non-squamous non-small cell lung cancer were enrolled. These patients constituted the total enrolled population, the Full Analysis Set (FAS), and the safety analysis Set. Both efficacy and safety were analyzed in these population.

A total of 52 patients were enrolled between July 12, 2022, and March 8, 2024.

[ Adverse events occurring in more than 80% of all Grades] Neutrophil count decreased: 43/52=82.7% Lymphocyte count decreased: 42/52=80.8% Anemia: 52/52=100% Platelet count decreased: 42/52=80.8% Hypoalbuminemia: 52/52=100% Blood lactate dehydrogenase increased: 46/52=88.5% Hyponatremia: 46/52=88.5% PS: 48/52=92.3% [ Adverse events occurring in more than 20% of Grade 3 or higher] White blood cell decreased : 20/52=38.5% Neutrophil count decreased : 26/52=50.0% Lymphocyte count decreased : 16/52=30.8% Anemia: 21/52=40.4% [ Incidence of Treatment-Related Death ] No treatment-related deaths occurred in this study. [ Incidence of Early Death ] In this study, there were 3 early deaths within 30 days of the final administration date. This number increased to 4 cases when including deaths within 30 days of treatment discontinuation. The cause of death was progression of the underlying disease in all cases. For these cases, the final treatment cycle was Cycle 1 for two patients and Cycle 3 for two patients.

Primary endpoint The primary endpoint, Progression free survival (PFS), was calculated for the FAS. The PFS was 4.9 month (80% confidence interval: 4.3 - 5.9). The primary endpoint was not met, because the lower limit of the 80% confidence interval for mPFS (4.3 months) could not exceed the threshold of 4.5 months. Secondary endpoints Overall survival(OS): OS was calculated for the FAS. The median OS(95% CI) was 13.2 months(10.3 - 27.2 months). Overall Response Rate(ORR): ORR was calculated for patients with target lesions (N=51) in the FAS .The ORR was 56.9% (N=29) Duration of response(DOR): DOR was calculated for patients in the FAS who achieved a response (N=29). The median DOR (95% CI) was 4.4 months (2.8 - 7.7 months). Time to Treatment Failure(TTF): TTF was calculated for the FAS. The median TTF(95% CI) was 4.6 months(4.2 - 5.6 months). Dose Intensity(DI) and Relative Dose Intensity(RDI): DI and RDI were calculated for the FAS. The mean / median Relative Dose Intensity (RDI) was as follows: nab-paclitaxel: 62.4% / 64.2% carboplatin: 80.7% / 85.1% atezolizumab: 57.0% / 60.0% atezolizumab(up to 4 weeks): 86.2% / 87.0% Adverse event rate As described in the "Adverse Events" section

This study was the first prospective interventional trial for patients with TTF-1-negative non-squamous non-small cell lung cancer. The primary endpoint, the progression free survival, was not met. TTF-1-negative non-squamous non-small cell lung cancer is a challenging subgroup with a poor prognosis and requires further treatment development.

Oct. 16, 2025

Oct. 16, 2025

https://www.ejcancer.com/article/S0959-8049(25)00565-9/fulltext

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCTs071220008

Okamoto Isamu

Kyushu University Hospital

3-1-1 Maidashi Higashi-ku Fukuoka,Japan

okamoto.isamu.290@m.kyushu-u.ac.jp

Shiraishi Yoshimasa

Kyushu University Hospital

3-1-1 Maidashi Higashi-ku Fukuoka,Japan

+81-92-642-5378

shiraishi.yoshimasa.258@m.kyushu-u.ac.jp

Complete

April. 27, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(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.

(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.

Both

TTF-1 negative treatment-naive advanced non-squamous non-small cell lung cancer

CBDCA AUC 6 (day1)+ nab-Paclitaxel 100mg/m2(day1,8,15)+ Atezolizumab 1200mg/body(day1), every 3 weeks, up to 4 cycles.
Atezolizumab 1200mg/body (day1), every 3 weeks, up to PD.

NSCLC, advanced, driver oncogene negative, TTF-1 negative

phase2

D002289

D017427

PFS: Progression-free survival

Overall survival
Response proportion
DOR: Duration of response
TTF: Time-to-treatment-failure
Dose intensity/Relative dose intensity
Safety(Adverse events of any grade, Incidence of treatment-related deaths, Incidence of early deaths)

+81-92-642-5082

Mar. 15, 2022

none