non-squamous non-small cell lung cancer
Conditions
Interventions
None listed
Sponsors
Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who have been registered in one of the following previous studies targeting TTF-1 negative advanced NSCLC and have received treatment with either Carboplatin + Nab-paclitaxel + Atezolizumab or Platinum-based chemotherapy + Pemetrexed + Pembrolizumab. These patients must have evaluable efficacy based on treatment results. i) Phase II Trial of Carboplatin + Nab-paclitaxel + Atezolizumab Combination Therapy for TTF-1 Negative Advanced Non-squamous NSCLC (F1NE-TUNE) ii) Multicenter Observational Study to Evaluate the Efficacy of Platinum-based Chemotherapy + Pemetrexed + Pembrolizumab in TTF-1 Negative Advanced Non-squamous NSCLC (KN189 Observational Study) (2) PS of 0-1. (3) Patients must meet one of the following conditions: (i) Stage III or IV NSCLC that is not amenable to curative radiation therapy. (ii) Post-surgical recurrence. (iii) Recurrence after curative radiation therapy to the trunk, with at least 168 days having passed since the last radiation session. (4) No previous systemic chemotherapy. Patients with no history of systemic pharmacological therapy for the cancer under investigation in this study. However, patients who have had recurrence after chemoradiation therapy are eligible if at least 168 days have passed since the last chemotherapy dose or the last chest radiation therapy. Furthermore, postoperative UFT treatment history is acceptable for registration regardless of the elapsed time from the last dose (excluding the drugs mentioned in Note 1). Note 1: Drugs targeting T-cell co-stimulation or checkpoint pathways, such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc. (5) No history of chemotherapy using the drugs listed in Note 1 for other cancer types. (6) The following criteria must be met for driver gene testing: i) Negative for EGFR gene mutations. ii) Negative or unknown for ALK fusion gene, ROS1 fusion gene, BRAF V600E mutation, MET exon 14 skipping mutation, RET fusion gene, or NTRK fusion gene.
Exclusion criteria
Exclusion criteria: (1) Patients with evident interstitial pneumonia identified on CT imaging. (2) Patients with a current autoimmune disease or a history of autoimmune disease that required steroid therapy. (However, patients with autoimmune-related hypothyroidism who are receiving a stable dose of thyroid hormone replacement therapy, or patients with well-controlled type 1 diabetes receiving a stable insulin regimen, are eligible.) (3) Patients with serious comorbidities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival | — |
Countries
Japan
Contacts
Public ContactKohei Otsubo
Graduate School of Medical Sciences, Kyushu University Department of Respiratory Medicine
Outcome results
None listed