Combining JNJ-90301900 with chemotherapy and radiation for advanced lung cancer
A Phase 2, Randomized, Open-Label, Active-Controlled Study of JNJ-90301900 in Combination With Chemoradiation Followed by Durvalumab in Locally Advanced and Unresectable Stage III NSCLC
This study is testing if adding a new drug called JNJ-90301900 to standard chemotherapy and radiation can help people with advanced lung cancer respond better to treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johnson & Johnson Enterprise Innovation Inc. Industry-sponsored |
| Drugs / interventions | durvalumab, chemotherapy, radiation, immunotherapy |
| Locations | 41 sites (Farmington, Connecticut and 40 other locations) |
| Trial ID | NCT06667908 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of JNJ-90301900 when added to standard concurrent platinum-based chemotherapy and radiation therapy, followed by consolidation immunotherapy, in patients with locally advanced and unresectable stage III non-small cell lung cancer (NSCLC). The goal is to improve the objective response rate, which measures the percentage of patients achieving a complete or partial response to treatment. Participants will receive a combination of chemotherapy agents, including carboplatin and paclitaxel, along with radiation therapy and the immunotherapy drug durvalumab. The study aims to determine if this combination can enhance treatment outcomes for this challenging cancer stage.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with locally advanced unresectable stage IIIA or IIIB NSCLC who are eligible for standard treatment involving chemotherapy and radiation.
Not a fit: Patients with primary immunodeficiency or those not suitable for the standard of care treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment responses in patients with advanced non-small cell lung cancer.
How similar studies have performed: Other studies have shown promising results with similar combinations of chemotherapy, radiation, and immunotherapy, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must be a candidate for standard of care (SOC) treatment of non small cell lung cancer (NSCLC) by concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed by consolidation durvalumab treatment as determined by the investigator and per local guidelines at screening * Have a medical history of pathologically (histologically or cytologically) proven diagnosis of NSCLC within 3 months prior to enrollment/randomization * Have locally advanced unresectable stage III NSCLC according to the eighth edition lung cancer stage classification * Have at least 1 target lesion (primary lung lesion or involved lymph node\[s\]) per RECIST version 1.1 that is amenable to intratumoral and/or intranodal injection and intensity modulated radiation therapy (IMRT) as determined by the investigator at screening * Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 Exclusion Criteria: * Medical history of: (a) Primary immunodeficiency (b) Organ transplant that requires therapeutic immunosuppression * Any of the following within 3 months prior to enrollment/randomization: severe or unstable angina, myocardial infarction, clinically significant ventricular arrhythmias or heart failure New York heart association functional classification class III to IV * Another concurrent or prior primary malignancy within the last 36 months at informed consent * Known allergies, hypersensitivity, or intolerance to any ingredients of JNJ-90301900 crystalline solution, platinum-based doublet chemotherapy (ChT), or durvalumab * History of coagulation disorders, including: (a) Active bleeding diathesis or requirement for therapeutic anticoagulation or antiplatelet that cannot be interrupted or altered for JNJ-90301900 injection procedures, (b) Major thromboembolic events (for example, pulmonary embolism, cerebrovascular accident) within 3 months of enrollment or randomization
Where this trial is running
Farmington, Connecticut and 40 other locations
- University of Connecticut Health Center — Farmington, Connecticut, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
- Orlando Health Cancer Institute — Orlando, Florida, United States (Recruiting)
- Emory University Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- FirstHealth of the Carolinas — Pinehurst, North Carolina, United States (Recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- Oregon Health And Science University — Portland, Oregon, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- University of Vermont Medical Center — Burlington, Vermont, United States (Recruiting)
- Royal Brisbane and Women's Hospital — Herston, Australia (Recruiting)
- Sir Charles Gairdner Hospital — Nedlands, Australia (Recruiting)
- Macquarie University — North Ryde, Australia (Recruiting)
- Royal Melbourne Hospital — Parkville, Australia (Recruiting)
- Fundacao Pio XII — Barretos, Brazil (Recruiting)
- Sociedade Beneficente de Senhoras Hospital Sirio Libanes — São Paulo, Brazil (Recruiting)
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein — São Paulo, Brazil (Recruiting)
- Dongguan People s Hospital — Dongguan, China (Recruiting)
- The First Affiliated Hospital Sun Yat sen University — Guangzhou, China (Recruiting)
- The Affiliated Cancer Hospital of Shandong First Medical University — Jinan, China (Recruiting)
- Hopital De La Cavale Blanche — Brest, France (Recruiting)
- Hopital Nord Marseille — Marseille, France (Recruiting)
- Hopital Tenon — Paris, France (Recruiting)
- Institut Curie — Paris, France (Recruiting)
- Gustave Roussy — Villejuif, France (Recruiting)
- Prince of Wales Hospital — Shatin, Hong Kong (Recruiting)
- Antoni van Leeuwenhoek — Amsterdam, Netherlands (Recruiting)
- Radboud Umcn — Nijmegen, Netherlands (Recruiting)
- Hosp. Univ. 12 de Octubre — Madrid, Spain (Recruiting)
- Clinica Univ. de Navarra — Pamplona, Spain (Recruiting)
- Hosp. Clinico Univ. de Santiago — Santiago de Compostela, Spain (Recruiting)
- Hosp. Univ. I Politecni La Fe — Valencia, Spain (Recruiting)
- Marmara University Pendik Training Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
- Sakarya University Training and Research Hospital — Sakarya, Turkey (Türkiye) (Recruiting)
- University College London Hospitals — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.