Tests pumitamig with chemotherapy in lung cancer first treatment
Tests pumitamig with chemotherapy in adults with newly diagnosed non-small cell lung cancer.
Plain-language title generated from the registry record
Registry title: Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)
Key facts
- Where
- Adelaide, Bedford Park, Cairns, Dubbo, Frankston, Joondalup, Kurralta Park, Melbourne, Orange, Southport, St Albans, Townsville, and Wollongong, AustraliaSee the 15 sites
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has your cancer come back or got worse during or after treatment with platinum chemotherapy?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
Source: NCT06712316, who can take part
Where in Australia
- Cancer Research SA (CRSA)Adelaide, AustraliaTaking people
- Royal Adelaide HospitalAdelaide, AustraliaTaking people
- Flinders Medical CentreBedford Park, AustraliaTaking people
- Cairns HospitalCairns, AustraliaTaking people
- Dubbo HospitalDubbo, AustraliaTaking people
- Peninsula & South Eastern Haematology and Oncology GroupFrankston, AustraliaTaking people
- Joondalup Health CampusJoondalup, AustraliaTaking people
- Icon Cancer Centre Kurralta ParkKurralta Park, AustraliaTaking people
- Monash University - Monash Health -Monash Medical CentreMelbourne, AustraliaTaking people
- Peter MacCallum Cancer CentreMelbourne, AustraliaTaking people
- Central West Cancer Care CentreOrange, AustraliaTaking people
- Clinical Trial Center-Tasman Oncology Research LtdSouthport, AustraliaTaking people
- Western Health Sunshine HospitalSt Albans, AustraliaTaking people
- ICON Cancer Care - TownsvilleTownsville, AustraliaTaking people
- Cancer Care Wollongong Pty LimitedWollongong, AustraliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BioNTech SE
- Trial code
- NCT06712316EU 2024-515764-31-00
- Record updated
- 2 November 2026
- Original description
This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC).Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; Have histologically or cytologically confirmed NSCLC with small-cell lung cancer or neuroendocrine histologic component; 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.