CARMEN-LC03

• Research type

  Research Study

• Full title

  Randomized, Open Label Phase 3 study of SAR408701 versus Docetaxel in Previously Treated metastatic Non-Squamous Non-Small Cell Lung Cancer patients with CEACAM5 positive tumors

• IRAS ID

  1005814

• Contact name

  N/A N/A

• Contact email

  uk-medicalinformation@sanofi.com

• Sponsor organisation

  Sanofi-aventis recherche & développement

• Eudract number

  2019-001273-81

• Clinicaltrials.gov Identifier

  NCT04154956

• Research summary

  This trial is for previously treated metastatic non- squamous Non-Small Cell Lung Cancer (NSCLC) patients with CEACAM5 positive tumours.
  Despite recent progress in the treatment of advanced NSCLC, there remains a need for effective new treatment at the time of disease progression. The study medication, tusamitamab ravtansine, is linked to an antibody that recognizes a protein called CEACAM5 expressed at the surface of some types of cancer including lung cancer. The antibody component of tusamitamab ravtansine binds to the CEACAM5 antigen expressed at the surface of the tumour cell. This could bring a clinical benefit and improved safety profile over the existing chemotherapy option.

  The trial aims to determine whether tusamitamab ravtansine improves the progression free survival and overall survival when compared to docetaxel in participants with metastatic nonsquamous NSCLC (expressing the CEACAM5 protein at the required levels and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI)). The study will also compare how the participants respond, the duration of response, the health QoL as well as the safety of the study drug.

  The duration of the study (from the signature of the main informed consent):
  • a screening period of up to 28 days
  • a treatment period [max 21-25 cycles or until disease progression]
  • an end-of-treatment visit at least approximately 30 days following the last administration of study drug (or until the participant receives another anticancer therapy,
  whichever is earlier)
  • follow-up visits 3 months after treatment discontinuation and every 3 months (or 2 months if other reason than progression) thereafter following, until radiological disease progression, death final study cut off or consent withdrawal whichever is earlier

  The study Sponsor is Sanofi and will be recruiting in approximately 26 countries and the study completion date is approximately 17-Feb-25.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  22/SC/0376

• Date of REC Opinion

  6 Jan 2023

• REC opinion

  Further Information Favourable Opinion