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NCT Number: NCT06667908

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to determine whether JNJ-90301900 added to concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed by consolidation immunotherapy (cIT) can improve objective response rate (ORR; that is percentage of participants whose best response is complete response or partial response during the study) in participants with locally advanced and unresectable stage III non-small cell lung cancer.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Brisbane and Women's Hospital, Herston, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-90301900

Drug

JNJ-90301900 will be injected intratumorally and/or intranodally.

Durvalumab

Biological

Durvalumab will be administered as intravenous (IV) infusion as cIT.

Concurrent Chemo/Radiation Therapy (cCRT)

Radiation

Radiation by intensity modulated radiation therapy (IMRT) will be administered.

Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin

Drug

Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.

Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel

Drug

Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.

Primary outcomes

  1. Objective Response Rate (ORR) Using Independent Central Review (ICR) Assessment

    Time frame: Up to 2 Years and 2 months

    ORR is defined as the percentage of participants who have a best response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1 using ICR assessments.

Secondary outcomes

  1. Objective Response Rate (ORR) Post-cCRT and Pre-cIT

    Time frame: Up to 12 Weeks

    Objective response rate is defined as percentage of participants who achieve CR or PR, post-concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) and pre-consolidation immunotherapy (cIT) based on investigator's assessment according to RECIST v1.1.

  2. Disease Control Rate (DCR) Post-cCRT and Pre-cIT

    Time frame: Up to 12 Weeks

    DCR is defined as percentage of participants who achieve CR, PR and stable disease post-cCRT and pre-cIT based on investigator's assessment according to RECIST v1.1.

  3. Objective Response Rate (ORR) as Assessed by the Investigator

    Time frame: Up to 2 Years and 2 months

    ORR is defined as the percentage of participants who have a best response of CR or PR using RECIST v1.1 as assessed by the investigator.

  4. Progression Free Survival (PFS)

    Time frame: Up to 2 Years and 2 months

    PFS is defined as the time from the enrollment/randomization until disease progression or death due to any cause according to RECIST v1.1.

  5. Duration of Response (DoR)

    Time frame: Up to 2 Years and 2 months

    DoR will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of relapse according to RECIST v1.1, or death due to any cause, whichever occurs first.

  6. Time to Locoregional Failure (LRF)

    Time frame: Up to 2 Years and 2 months

    Time to LRF is defined as the time from enrollment/randomization to the first LRF using ICR assessments.

  7. Time to Distant Failure (DF)

    Time frame: Up to 2 Years and 2 months

    Time to DF is defined as the time from enrollment/randomization to the first DF using ICR assessments.

  8. Number of Participants with Treatment-Emergent Adverse Event (TEAE) Related to Study Treatment

    Time frame: Up to 2 Years and 2 months

    TEAE is defined as any new or worsening adverse event (AE) occurring at or after the initial administration of study treatment through the day of last dose of study treatment received plus 30 days or prior to the start of subsequent anticancer therapy (non-durvalumab), whichever is earlier, or any follow-up AE with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent anticancer therapy, or any AE that is considered treatment-related regardless of the start date of the event. TEAEs related to JNJ-90301900 injection procedure, JNJ-90301900, RT, ChT, or cIT will be reported.

  9. Number of Participants Reporting Laboratory Parameters, Physical Examination, Vital Signs Including Eastern Cooperative Oncology Group (ECOG) Performance Status Abnormalities

    Time frame: Up to 2 Years and 2 months

    Participants with laboratory parameters, physical examination, vital signs including ECOG performance status abnormalities will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Enterprise Innovation Inc.

Industry

Registry information

Official study title

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

Acronym: CONVERGE

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 31, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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