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A Phase 2 study of JNJ-90301900 with chemoradiation and durvalumab for non-small cell lung cancer
EU CTIS ID: 2024-518276-32-00
What this study is testing
To determine whether JNJ-90301900 as a radioenhancer added to cCRT followed by cIT can improve objective response rate (ORR) in participants with locally advanced and unresectable Stage III NSCLC
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Have locally advanced and unresectable stage III lung cancer
- Pathologically (histologically or cytologically) proven diagnosis of NSCLC within 3 months prior to enrollment/randomization. Pathologic mediastinal staging with mediastinoscopy, mediastinotomy, EBUS, EUS, and/or CT guided biopsy is required when deemed technically feasible and clinically appropriate.
- A candidate for standard of care treatment of study cancer by cCRT followed by consolidation durvalumab treatment
- Have at least one target lesion (primary lung lesion or involved lymph nodes) planned to receive the full dose of prescribed RT [60 Gy]) per RECIST 1.1 that is amenable to intratumoral or intranodal injection and external-beam irradiation and IMRT as determined by the investigator at screening.
- Have documented tumor proportion score (TPS) of PD-L1 by local or central lab
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
You likely can't join if
- Have mixed small cell and non-small cell lung cancer histology
- Prior systemic ChT for lung cancer within the prior 36 months at informed consent
- Participant received prior intrathoracic RT that would overlap with the current study PTV for lung cancer, or recommended normal tissue constraints are exceeded when creating a summation of the prior and current radiation plans. Prior RT is allowable only if the treatment is >36 months at informed consent and does not interfere with the study lesion assessment; RT to chest wall, such as for early-stage breast cancer or skin cancer, is allowable
- Contraindications to the use of JNJ-90301900 per the IB or platinum-based doublet ChT or durvalumab per local prescribing information
See the full eligibility criteria
- Have locally advanced and unresectable stage III lung cancer
- Pathologically (histologically or cytologically) proven diagnosis of NSCLC within 3 months prior to enrollment/randomization. Pathologic mediastinal staging with mediastinoscopy, mediastinotomy, EBUS, EUS, and/or CT guided biopsy is required when deemed technically feasible and clinically appropriate.
- A candidate for standard of care treatment of study cancer by cCRT followed by consolidation durvalumab treatment
- Have at least one target lesion (primary lung lesion or involved lymph nodes) planned to receive the full dose of prescribed RT [60 Gy]) per RECIST 1.1 that is amenable to intratumoral or intranodal injection and external-beam irradiation and IMRT as determined by the investigator at screening.
- Have documented tumor proportion score (TPS) of PD-L1 by local or central lab
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Life expectancy ≥6 months at Consent
- Have mixed small cell and non-small cell lung cancer histology
- Prior systemic ChT for lung cancer within the prior 36 months at informed consent
- Participant received prior intrathoracic RT that would overlap with the current study PTV for lung cancer, or recommended normal tissue constraints are exceeded when creating a summation of the prior and current radiation plans. Prior RT is allowable only if the treatment is >36 months at informed consent and does not interfere with the study lesion assessment; RT to chest wall, such as for early-stage breast cancer or skin cancer, is allowable
- Contraindications to the use of JNJ-90301900 per the IB or platinum-based doublet ChT or durvalumab per local prescribing information
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Turkey
- China
- United Kingdom
- Hong Kong
- United States
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Turkey; China; United Kingdom; Hong Kong; United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.