NCT07908537Toborzás még nem indult3. fázis
A Clinical Trial of Gocatamig (MK-6070) With Durvalumab in Participants With Small Cell Lung Cancer (MK-6070-004)
A Phase 3 Randomized Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) in Combination With Durvalumab Compared to Durvalumab Alone as Consolidation Therapy in Participants With Limited-Stage Small Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 2.
Rövid összefoglaló (regiszter, angolul)
Researchers are looking for new ways to treat limited-stage small cell lung cancer (LS-SCLC). LS-SCLC is a type of lung cancer that has not spread from the lung to other parts of the body. Researchers want to learn if gocatamig given with durvalumab can treat LS-SCLC. The main goal of this trial is to learn if participants who receive gocatamig with durvalumab live longer without the cancer getting worse than those who receive durvalumab alone.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 564 (tervezett)
- Első benyújtás
- 2026. okt. 26.
- Kezdés
- 2026. dec. 7.
- Elsődleges befejezés
- 2031. dec. 8.
- Fő szponzor
- Merck Sharp & Dohme LLC
- Betegségek
- Tüdőrák
- NCT-szám
- NCT07908537
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 3. fázis
- Tervezett résztvevők: 564
- 2026. dec. 7. és az elsődleges befejezés (2031. dec. 8.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Has received sequential CRT for LS-SCLC (no overlap of radiotherapy with chemotherapy)
- Has clinical or radiographic progression or deterioration while on concurrent CRT
- Is expected to require any other form of antineoplastic therapy while on study
- Has not adequately recovered from major surgery or has ongoing surgical complications
Más betegség
- Has active or history of immune deficiency (with the exception of well-controlled HIV on ART)
- Has history of Kaposi's sarcoma and/or Multicentric Castleman's Disease, if diagnosed with HIV
- Has known additional malignancy that is progressing or required active treatment within the past 3 years
- Has known central nervous system metastases or leptomeningeal disease
- Has active autoimmune disease that required systemic treatment in the past 2 years
- Has active infection requiring systemic therapy (other than therapies permitted per protocol)
- Has active or history of neurologic paraneoplastic syndrome
- Has current pneumonitis/interstitial lung disease (ILD) or history of noninfectious pneumonitis/ILD that required steroids
- Has uncontrolled or significant cardiovascular disease
- Has clinically severe pulmonary compromise from intercurrent pulmonary illnesses
- Has history of clinically significant intracranial or spinal cord bleeding
- Has history of allogeneic tissue/solid organ transplant
Egyéb
- The main exclusion criteria include but are not limited to the following:
- Has pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Kiket keres a vizsgálat
- The main inclusion criteria include but are not limited to the following:
- Has histologically or cytologically confirmed limited-stage small cell lung cancer (LS-SCLC) defined as Stage I-III by American Joint Committee on Cancer 9th Edition Cancer Staging
- Has received appropriate definitive concurrent chemoradiotherapy (CRT; 4 cycles of platinum-based chemotherapy concurrent with radiotherapy) per protocol
- Has achieved complete response, partial response, or stable disease and did not progress per protocol following definitive, platinum-based chemotherapy concurrent with radiotherapy
- Is not expected to require tumor resection during the study
- Is able to submit a biopsy of a tumor lesion not previously irradiated
- Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART), if diagnosed with HIV
- Has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy, if hepatitis B surface antigen-positive
- Has undetectable hepatitis C virus (HCV) viral load, if has a history of HCV infection
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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