Inoperable, mutation-negative (EGFR/ALK/ROS1/BRAF V600E), PD-L1 positive(TPS =1%), locally advanced NSCLC
Conditions
Interventions
Experimental arm:Synchronous radioimmunotherapy period: the intravenous infusion of evoximab at 20mg/kg will be started on the first day after enrollment, once every three weeks, two cycles. The seque
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years; 2.ECOG performance status 0–1 with no deterioration within 2 weeks before enrollment; 3.Minimum life expectancy >= 12 weeks; 4.Histologically or cytologically confirmed NSCLC, newly diagnosed unresectable locally advanced disease (stage IIIA/IIIB/IIIC, AJCC 8th edition); 5.Post-operative loco-regional recurrence (no prior radiotherapy; no prior chemotherapy or >= 24 weeks since last chemotherapy). Recurrence must be re-biopsy-proven NSCLC; 6.PD-L1 TPS = 1 % documented within 6 months before enrollment (primary or recurrent lesion); 7.At least one measurable target lesion per RECIST 1.1 suitable for accurate repeated measurement; 8.Adequate organ function (no prohibited support within specified windows): (1) Haematology (7 days before first dose): 1). ANC >= 1.5 × 10^9/L ;2). Platelets >= 100 × 10^9/L ;3). Hb >= 90 g/L ; (2) Renal: 1).. Calculated CrCl >= 50 mL/min (Cockcroft-Gault);2). Urine protein = 28 g/L; (4) Coagulation: INR & aPTT = 50 %; 9.Women of child-bearing potential must use effective contraception from screening through 3 months after last dose and must not breast-feed. Negative serum pregnancy test required unless: (1). Post-menopausal (age > 50 y and >= 12 months amenorrhoea off HRT), or (2). Age = 12 months amenorrhoea off HRT and post-menopausal LH/FSH levels, or (3). Documented irreversible sterilisation (hysterectomy, bilateral oophorectomy, or salpingectomy; tubal ligation excluded); 10.Men must use barrier contraception from screening through 3 months after last dose; 11.Signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Small-cell carcinoma component on histopathology; 2.EGFR-sensitising mutation, ALK fusion, BRAF V600E mutation, or ROS1 fusion. Non-squamous or never-smoker squamous patients must provide tissue-based molecular report = 200 IU/mL) or active HCV (HCV-RNA detectable); 16.Major surgery = Grade 3 = 160 or DBP >= 100 mmHg on meds); 23.Bleeding diathesis; significant haemoptysis Grade 1 from prior anti-cancer therapy (except alopecia) per CTCAE v5.0; 25.Live vaccine 20 × 10^9/L, cachexia > 10 % weight loss within 3 months) that could confound survival assessmentl 31.Any other circumstance deemed by the investigator to render the patient unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response;Quality of life;Time to response;Safety;Disease control rate;1-year overalll survival rate;Objective response rate; | — |
Countries
China
Contacts
Public ContactQifeng Wang
Sichuan Cancer Hospital
Outcome results
None listed