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Taking people in JapanPhase 2/3

Tests pumitamig with chemotherapy in lung cancer first treatment

Tests pumitamig with chemotherapy in adults with newly diagnosed non-small cell lung cancer.

Key facts

Who runs it
BioNTech SE
Where
Ageo, Akashi, Aomori, Bunkyō City, Chūōku, Funabashi, Himeji, Hiroshima, Iizuka, Iwakuni, Kanagawa, Kanazawa, Kumamoto, Kurashiki, Kurume, Matsusaka, Matsuyama, Meguro City, Mibu, Morioka, Nagaizumi-chō, Nagasaki, Nagoya, Niigata, Nishinomiya, Osaka, Saitama, Sakai, Sapporo, Sendai, Shibukawa, Toyama, Wakayama, and Yokohama, JapanSee the 38 sitesAlso in 21 other countries, 355 sites
Registry title
Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)
Status
Recruiting
Phase
Phase 2/3
People taking part
1,580 people, planned
Started
7 Jan 2025
Expected to end
Dec 2031
Type of study
Interventional, 10 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Pumitamig
  • Pembrolizumab
  • Carboplatin
  • Pemetrexed
  • Paclitaxel
Record updated
2 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced non-small cell lung cancer who have not yet had any drug treatment for it.

Age
18 years and older
Sex
Men and women can both join.
Disease stage
Stage IIIB or IIIC non-small cell lung cancer that cannot be treated with surgery or radiotherapy meant to remove all of the disease, or Stage IV. At least one measurable tumour is needed.
Earlier treatment
No earlier drug treatment for this cancer. Earlier platinum-based chemotherapy, PD(L)-1 treatment, anti-VEGF antibody or PD(L)-1/VEGF bispecific antibody means a person cannot join.

Main reasons for not taking part

  • Small-cell lung cancer or neuroendocrine cells in the tumour
  • Systemic corticosteroids above 10 mg/day of prednisone within 7 days before treatment starts
  • Uncontrolled high blood pressure or poorly controlled diabetes
  • Serious or non-healing wound, incompletely healed bone fracture, or fistula or gut perforation
  • Superior vena cava syndrome or signs of spinal cord compression

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in Japan

Also in 21 other countries, 355 sites

  • Ageo Central General HospitalAgeo, JapanTaking people
  • Hyogo Cancer CenterAkashi, JapanTaking people
  • Aomori Prefectural Central HospitalAomori, JapanTaking people
  • Tokyo Metropolitan Komagome HospitalBunkyō City, JapanTaking people
  • Hamamatsu University HospitalChūōku, JapanTaking people
  • Funabashi Municipal Medical CenterFunabashi, JapanTaking people
  • National Hospital Organization Himeji Medical CenterHimeji, JapanTaking people
  • Hiroshima Prefectural HospitalHiroshima, JapanTaking people
  • Hiroshima University HospitalHiroshima, JapanTaking people
  • Aso Iizuka HospitalIizuka, JapanTaking people
  • National Hospital Organization Iwakuni Clinical CenterIwakuni, JapanTaking people
  • Shonan Kamakura General HospitalKanagawa, JapanTaking people
  • Ishikawa Prefectural Central HospitalKanazawa, JapanTaking people
  • Social Welfare Organization Imperial Gift Foundation, Inc. Saiseikai Kumamoto HospitalKumamoto, JapanTaking people
  • Kurashiki Central HospitalKurashiki, JapanTaking people
  • Kurume University HospitalKurume, JapanTaking people
  • Matsusaka Municipal HospitalMatsusaka, JapanTaking people
  • National Hospital Organization Shikoku Cancer CenterMatsuyama, JapanTaking people
  • National Hospital Organization Tokyo Medical CenterMeguro City, JapanTaking people
  • Dokkyo Medical University HospitalMibu, JapanTaking people
  • Iwate Medical University HospitalMorioka, JapanTaking people
  • Shizuoka Cancer CenterNagaizumi-chō, JapanTaking people
  • Nagasaki University HospitalNagasaki, JapanTaking people
  • Japan Community Healthcare Organization Chukyo HospitalNagoya, JapanTaking people
  • Nagoya University HospitalNagoya, JapanTaking people
  • National Hospital Organization Nagoya Medical CenterNagoya, JapanTaking people
  • Niigata Cancer Center HospitalNiigata, JapanTaking people
  • Hyogo Medical University HospitalNishinomiya, JapanTaking people
  • Osaka Prefectural Hospital Organization - Osaka International Cancer InstituteOsaka, JapanTaking people
  • Saitama Prefectural Cancer CenterSaitama, JapanTaking people
  • NHO Kinki-Chuo Chest Medical CenterSakai, JapanTaking people
  • Sapporo Minamisanjo HospitalSapporo, JapanTaking people
  • Teine Keijinkai HospitalSapporo, JapanTaking people
  • Sendai Kousei HospitalSendai, JapanTaking people
  • Shibukawa Medical CenterShibukawa, JapanTaking people
  • Toyama University HospitalToyama, JapanTaking people
  • Wakayama Medical University HospitalWakayama, JapanTaking people
  • Yokohama Municipal Citizen's HospitalYokohama, JapanTaking people

About the trial

What the trial wants to find out

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

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.

The 10 groups in the trial

  • Substudy A Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + PemetrexedTreatment being tested

    Treatment: Pumitamig, Carboplatin, and Pemetrexed

  • Substudy A Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + PemetrexedTreatment being tested

    Treatment: Pumitamig, Carboplatin, and Pemetrexed

  • Substudy A Phase 2 (Arm 1A - China only) - Pumitamig Dose 3 + Carboplatin + PemetrexedTreatment being tested

    Treatment: Pumitamig, Carboplatin, and Pemetrexed

  • Substudy A Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + PemetrexedTreatment being tested

    Treatment: Pumitamig, Carboplatin, and Pemetrexed

  • Substudy A Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + PemetrexedExisting treatment, for comparison

    Treatment: Pembrolizumab, Carboplatin, and Pemetrexed

  • Substudy B Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + PaclitaxelTreatment being tested

    Treatment: Pumitamig, Carboplatin, and Paclitaxel

  • Substudy B Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + PaclitaxelTreatment being tested

    Treatment: Pumitamig, Carboplatin, and Paclitaxel

  • Substudy B Phase 2 (Arm 1A, China only) - Pumitamig Dose 3 + Carboplatin + PaclitaxelTreatment being tested

    Treatment: Pumitamig, Carboplatin, and Paclitaxel

  • Substudy B Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + PaclitaxelTreatment being tested

    Treatment: Pumitamig, Carboplatin, and Paclitaxel

  • Substudy B Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + PaclitaxelExisting treatment, for comparison

    Treatment: Pembrolizumab, Carboplatin, and Paclitaxel

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests pumitamig with chemotherapy in lung cancer first treatmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06712316, who can take part
Record updated
2 November 2026