BNT327 with Chemotherapy for Lung Cancer

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

Recruiting Phase 2 Phase 3 Interventional Study
Non-small Cell Lung Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
1,580 (estimated)
Sponsor
BioNTech SE · Industry
Who this trial is looking for

This trial is looking for people with advanced non-small cell lung cancer who have not received any treatment yet. Participants will receive a new treatment combined with chemotherapy and will be monitored for their health outcomes.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with Stage IIIB, IIIC, or IV non-small cell lung cancer.
  • I have at least one measurable lesion.
  • My performance status is 0 or 1.
  • I have adequate organ function.

You may not be able to join if

  • I have small-cell lung cancer or neuroendocrine lung cancer.
  • I have received platinum-based chemotherapy or PD(L)-1 therapy for lung cancer before.
  • I have taken corticosteroids in the past 7 days.
  • I have uncontrolled high blood pressure or poorly controlled diabetes.
  • I have a serious or non-healing wound.
  • I have a significant risk of bleeding.
  • I have superior vena cava syndrome or symptoms of spinal cord compression.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This Trial

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.

Trial Locations
Loading…

Loading trial locations…

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 sy…
Contacts

BioNTech clinical trials patient information

+49 6131 9084

patients@biontech.de

CONTACT