NCT07524257Visszavonva3. fázis
Phase 3 Study of Nogapendekin Alfa Inbakicept Plus Standard of Care vs Standard of Care in First-Line Advanced or Metastatic NSCLC
Phase 3, Randomized, Open-Label Study of Nogapendekin Alfa Inbakicept in Combination With Standard of Care Versus Standard of Care as First-Line Treatment for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jún. 22.
Megadott ok: Sponsor decision
Rövid összefoglaló (regiszter, angolul)
This is a randomized, open-label, phase 3 study evaluating nogapendekin alfa inbakicept (NAI) plus chemoimmunotherapy containing pembrolizumab and platinum-based chemotherapy versus chemoimmunotherapy alone as first-line treatment in patients with stage IV squamous or nonsquamous non-small cell lung cancer (NSCLC) without actionable genomic alterations. Primary endpoint is progression-free survival by RECIST v1.1 based on blinded independent central review.
- Állapot (regiszter)
- Visszavonva
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 0 (tényleges)
- Első benyújtás
- 2026. márc. 26.
- Kezdés
- 2026. máj. 29.
- Elsődleges befejezés
- 2029. máj. 15.
- Fő szponzor
- ImmunityBio, Inc.
- Betegségek
- Tüdőrák
- NCT-szám
- NCT07524257
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Serious uncontrolled concomitant disease.
- Prior organ transplant requiring immunosuppression.
- Prior pneumonitis/interstitial lung disease requiring active systemic treatment.
- Prior systemic chemotherapy or immunotherapy within 3 years.
- Requirement for other anticancer therapy while on study (palliative RT allowed).
- Concomitant medications known to interact adversely with study drugs.
- Participation in another investigational drug/device study (except hormone-lowering therapy).
Más betegség
- Certain prior malignancies (exceptions: adequately treated or nonmetastatic, as per protocol).
- Active autoimmune disease requiring systemic treatment (exceptions: autoimmune thyroiditis, etc.).
- HIV infection or active/uncontrolled HBV/HCV not meeting the protocol's controlled criteria.
- Active infection requiring IV therapy.
- Significant cardiovascular disease (uncontrolled HTN, recent MI, stroke, CHF ≥NYHA II, serious arrhythmia).
- Known hypersensitivity to study drugs.
- Any condition or noncompliance that, in Investigator judgment, precludes participation.
Laborértékek
- ANC <1,500/mm³; platelets <100,000/mm³; Hgb <9 g/dL.
- Total bilirubin >1.5×ULN (with defined Gilbert's exception).
- AST/ALT >1.5×ULN (or >5×ULN with liver mets).
- ALP >2.5×ULN (or >5×ULN with bone mets).
- Creatinine clearance <40 mL/min (Cockcroft-Gault).
Egyéb
- Body weight <40 kg.
- Known CNS metastases, carcinomatous meningitis, and/or spinal cord compression (with specified exceptions for treated or asymptomatic brain mets).
- Inadequate organ function:
- Pregnancy or breastfeeding.
- Confinement by court order/authority.
Kiket keres a vizsgálat
- Age ≥18 years.
- Pathologically confirmed stage IV NSCLC (squamous or nonsquamous).
- No prior systemic chemotherapy for advanced/metastatic NSCLC.
- Tumor lacks an actionable genomic alteration with approved first-line targeted therapy (EGFR, ALK etc.; AGA status from local or central testing; ctDNA acceptable if tissue unavailable).
- PD L1 result available before randomization: TPS ≥1%, <1%, or unknown.
- ECOG performance status 0-1.
- At least one measurable lesion per RECIST v1.1.
- Able to attend visits and follow-up.
- Contraception requirements for women of childbearing potential and nonsterile males, with 7 month post-last-dose window.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.