Unresectable locally advanced stage III, prostate cell lung cancer
Conditions
Interventions
Experimental Group A (Part 1):JNJ-90301900 was administered at a dose level of 22% GTV
Experimental Group A (Part 2):JNJ-90301900 at a dose level of 22% GTV was used as an intratumoral radiation enhancer combined with cCRT followed by cIT
Experimental Group B (Part 2):JNJ-90301900 at a dose level of 33% GTV was used as an intratumoral radiation enhancer combined with cCRT followed by cIT
Control group:cIT was performed after receiving cCRT only
Experimental Group B (Part 1):JNJ-90301900 was administered at a dose level of 33% GTV
Sponsors
Shandong First Medical University Affiliated Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The age at signing the informed consent form should be >= 18 years old. 2. For the candidate subjects with non-small cell lung cancer (NSCLC), they will receive cCRT SOC treatment, followed by durvalumab consolidation therapy. 3. The expected lifespan at the time of signing the informed consent form should be >= 6 months. 4. Before enrollment/randomization, the subjects diagnosed with NSCLC through pathology within 3 months should have a pathological mediastinal staging through mediastinoscopy, mediastinal incision, EBUS, EUS, or CT-guided biopsy when technically feasible and clinically appropriate. 5. At the screening stage, the subjects diagnosed with unresectable locally advanced stage III NSCLC as determined by the investigator. 6. According to RECIST version 1.1, there should be at least one target lesion (primary pulmonary lesion or involved lymph nodes). 7. There should be a recorded PD-L1 tumor cell positive proportion score (TPS) within 3 months before enrollment/randomization. 8. At the screening stage, there should be no known EGFR and ALK mutations. 9. At least 50% of the gross tumor volume should be available for injection. 10. The ECOG performance status score should be 0-1. 11. The organs, bone marrow hematological functions should be good. 12. The subjects receiving the study treatment should not be pregnant, breastfeeding, or donating gametes for assisted reproductive purposes. They must use at least one highly effective contraceptive method, such as oral contraceptives combined with barrier contraception. Couples with fertility should also use highly effective contraceptive methods, unless the subject has undergone vasectomy. 13. The ICF must be signed, indicating that the subject understands the purpose of the study and the required procedures, and is willing to participate in this study. 14. The subjects should be willing and able to follow the lifestyle restrictions stipulated in the study protocol.
Exclusion criteria
Exclusion criteria: 1. Evidence of ipsilateral or contralateral scalene or supraclavicular lymph node involvement. 2. Tumors with invasion/encasement of great vessels or esophagus, baseline presence of fistula, and/or malignant airway obstruction that requires endoscopic intervention. 3. Has uncontrolled illness. 4. Has a history of clinically significant cardiovascular disease within 3 months prior to randomization. 5. Has a QTcF interval >480 msec on screening ECG. 6. Another concurrent or prior primary malignancy within the last 36 months at informed consent. 7. Medical history of: a. Primary immunodeficiency. b. Organ transplant that requires therapeutic immunosuppression. 8. Known allergies, hypersensitivity, or intolerance to any ingredients of JNJ-90301900 crystalline solution, platinum-based doublet chemotherapy or durvalumab. 9. 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/randomization. 10. Active hepatitis of infectious origin. 11. Positive for human immunodeficiency virus (HIV) antibody testing and if they meet any 1 of the criteria specified in the protocol. 12. Have mixed small cell and non-small cell lung cancer histology. 13. Presence of metastatic disease (M1). 14. Primary tumor status is not able to be assessed (TX). 15. Have a calculated total gross tumor volume >909 milliliter (mL). 16. Participant received prior systemic anticancer therapy within the prior 36 months at informed consent. 17. Participant received prior intrathoracic radiation therapy that would overlap with the current study PTV or recommended normal tissue constraints are exceeded. 18. Contraindications to the use of JNJ-90301900 or platinum-based doublet ChT or durvalumab. 19. Received an investigational treatment or used an invasive investigational medical device within 30 days before the randomization or received an investigational biological product within 3 months or 5 half-lives, whichever is longer, before the randomization, or is currently enrolled in an investigational study. 20. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments (for example, non-compliance with study visits). 21. Employee of the sponsor, investigator, or study site with direct involvement in the proposed study or other studies under the direction of that sponsor, investigator, or study; 22. Participants who are incarcerated, including prisoners or subjects compulsorily detained for treatment of psychiatric disease. 23. Participants who withdraw consent before enrollment/randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Optimal relief rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory parameters, physical examination, vital signs were reported;Adverse events;Objective response rate;The time of the distant shift;Disease control rate;Duration of relief;Progression-free survival period;Time to local disease progression; | — |
Countries
China
Contacts
Public ContactYu Jinming;Meng Xue
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed