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RecruitingPhase 2 / Phase 3

Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)

A Phase II/III, Multisite, Randomized Master Protocol for a Global Trial of BNT327 in Combination With Chemotherapy and Other Investigational Agents in First-line Non-small Cell Lung Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 64 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The planned study duration per study participant is up to 64 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests BNT327 with chemotherapy and other study drugs as a first treatment for advanced non-small cell lung cancer (NSCLC). It looks at safety, how well treatment works, and how the body handles BNT327. The study has two parts based on the type of NSCLC.

This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC). This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have NSCLC confirmed by testing tissue or cells, with no prior cancer treatment that acts throughout the body.
  • Have stage IIIB or IIIC cancer that cannot be cured with surgery or radiation, or stage IV cancer.
  • Have at least one tumor that can be measured. If the only tumor was treated locally before, scans must show it has grown. A single cancer spot in bone, the brain, or the spinal cord does not count.
  • Be fully active, or able to walk and do light work despite limits on hard physical activity.
  • Have organs that work well enough under the study rules.

Who can't join

  • Have NSCLC that also contains small-cell lung cancer or neuroendocrine cancer cells.
  • Have had platinum chemotherapy or PD-1/PD-L1 immune treatment for NSCLC, or certain antibody drugs that block VEGF or both PD-1/PD-L1 and VEGF.
  • Have used steroids that act throughout the body above 10 mg of prednisone a day, or an equal dose, within 7 days before treatment. Some local steroids and short courses are allowed.
  • Have uncontrolled high blood pressure or poorly controlled diabetes.
  • Have a serious or unhealed wound or broken bone; certain abnormal openings, holes, or pus pockets in the belly or between the food pipe and windpipe; or swollen veins in the stomach or food pipe. Some problems within the past 6 months, or a risk of them, also count.
  • Have a high risk of serious bleeding, as judged by the study doctor.
  • Have blockage of the main vein carrying blood from the upper body to the heart, or symptoms of pressure on the spinal cord.
  • Other study rules for who can and cannot join also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: * Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 9th edition. * Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion). * Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Adequate organ function as defined in the protocol. Key Exclusion Criteria: * Have histologically or cytologically confirmed NSCLC with small-cell lung cancer or neuroendocrine histologic component. * Have received any of the following therapies or drugs within the noted time intervals prior to study treatment: * Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neoadjuvant/adjuvant or locally advanced/metastatic setting. * Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody. * Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\<=7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed. * Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment. * Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing fistula/perforation. * Participants with significant risk of hemorrhage (per investigator clinical judgment). * Participants have superior vena cava syndrome or symptoms of spinal cord compression. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Study sites (53)

AK

AL

CA

CO

DC

FL

GA

IA

IN

KY

MD

MO

NC

NE

NJ

NY

OH

OK

TN

TX

UT

VA

WI

WV