Non-squamous non-small cell lung cancer (NSCLC) Interstitial lung disease (ILD) non-small cell lung cancer, Interstitial lung disease, immune checkpoint inhibitor, anti-angiogenic agent, cytotoxic chemotherapy
Conditions
Interventions
Combination therapy with carboplatin, paclitaxel, bevacizumab, and atezolizumab
Sponsors
Taniguchi Yoshihiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Stage III/IV or postoperative recurrent non-squamous non-small cell lung cancer (non SQ NSCLC) with interstitial lung disease Including NSCLC with EGFR mutation or ALK fusion gene No prior systemic chemotherapy Age 18 years or older ECOG performance status 0 to1 No honeycomb lung on chest CT Predicted vital capacity eighty percent or higher
Exclusion criteria
Exclusion criteria: 1. Active double cancer (synchronous/multiple cancers or metachronous/multiple cancers within 2 years requiring treatment) 2. Ongoing infectious disease requiring systemic therapy 3. Fever of thirty eight degrees Celsius or higher at registration 4. Pregnant, possibly pregnant, planning pregnancy, within 28 days postpartum, breastfeeding women, or men planning pregnancy 5. Psychiatric disease or symptoms interfering with daily life and deemed unsuitable for trial participation 6. Continuous systemic administration (oral or IV) of corticosteroids >10 mg/day (prednisolone equivalent) or other immunosuppressive agents (e.g., infliximab, cyclophosphamide, mycophenolate mofetil, cyclosporine, azathioprine, tacrolimus, tocilizumab). Local therapies (inhaled, topical, ocular, nasal steroids) are allowed 7. Uncontrolled diabetes mellitus despite appropriate therapy (well-controlled insulin use is acceptable) 8. Symptomatic congestive heart failure, unstable angina (within 3 weeks), or history of myocardial infarction within 6 months 9. Positive for HBs antigen 10. Positive for HIV antibody (testing not mandatory) 11. Known hypersensitivity to atezolizumab components or polysorbate 80 12. History or presence of hemoptysis more than two point five milliliters fresh blood, suspected major vessel invasion, endobronchial lesion involving segmental bronchi, arterial or venous thromboembolic disease, uncontrolled hypertension, severe proteinuria two plus or higher, gastrointestinal perforation including history, surgery within twenty eight days, or thoracic radiotherapy within one hundred sixty eight days prior to treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) Objective response rate (ORR) Progression free survival (PFS) Safety Incidence of interstitial lung disease (ILD) exacerbation, all grades and grade three or higher Six month and one year PFS rates Subgroup analyses according to ILD background Efficacy according to PD L1 expression status | — |
Contacts
Public ContactShun-ichi Isa
NHO Kinki Chuo Chest Medical Center
Outcome results
None listed