A study of new drug comparing with standard chemotherapy treatment (Docetaxel) in previously treated stage 4 lung cancer patients.
- Conditions
- Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2023/07/055189
- Lead Sponsor
- Sanofi-Aventis Recherche & Développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
Participants are eligible to be included in the study only if all of the following criteria apply:
Age
I 01 Participant must be = 18 years of age (or country’s legal age of majority if >18 years) at the time of signing the informed consent.
Type of participant and disease characteristics
I 02 Histologically or cytologically proven diagnosis of non-squamous NSCLC metastatic disease at study entry; - meeting all 3 of the following criteria:
a) Having progressive disease during or after platinum-based chemotherapy (at least 2 cycles).
Maintenance therapy following platinum-based chemotherapy is not considered as a separate regimen. Adjuvant/neoadjuvant treatment for a patient who had a relapse with metastatic disease during or within 6 months of completion of treatment will be considered as first line treatment.
AND
b) Having progressive disease during or after one immune checkpoint inhibitor (anti- PD1/PD-L1); this could be given as monotherapy or in combination with platinum-based chemotherapy (whatever the order).
AND
c) Participant with EGFR sensitizing mutation or BRAF mutation or ALK/ROS alterations must be able to demonstrate progression of the disease on approved treatments for these conditions, in addition to platinum-based chemotherapy and immune checkpoint inhibitor.
I 03 Participants with CEACAM5 expression of =2+ in intensity in archival tumor sample (or if not available fresh biopsy sample) involving at least 50 % of the tumor cell population as demonstrated prospectively by a centrally assessed ICH assay. At least 7 × 4 µm slides from FFPE tumor tissue are required. If less material is available, patient could still be eligible after discussion with the Sponsor who will assess and confirm that there is sufficient relevant material for key evaluations.
I 04 At least one measurable lesion by RECIST v1.1 as determined by local site investigator /radiology assessment. Irradiated lesion can be considered measurable only if progression has been demonstrated on irradiated lesion.
I 05 Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Sex
I 06 Male or female
Contraceptive use by men or women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical studies.
a) Male participants
Male participants: A male participant must agree to use contraception methods (see Appendix 5, Section 10.5) during the intervention period and for at least 6 months after the last dose of study intervention. Men being treated with docetaxel should be advised to seek advice on conservation of sperm prior to treatment.
b) Female participants
Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix 5, Section 10.5), not breastfeeding, and at least one of the following
conditions applies:
Not a woman of childbearing potential (WOCBP)
OR
A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 7 months after the last dose of study intervention.
Informed Consent
I 07 Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Participants are excluded from the study if any of the following criteria apply:
Medical conditions
E 01 Untreated brain metastases or history of leptomeningeal disease. Patients with previously treated brain metastases may participate provided they are stable (i.e., without evidence of
progression) by imaging performed at least 4 weeks after CNS-directed treatment and at least 2 weeks prior to the first administration of study intervention, and any neurologic symptoms have returned to baseline; and there is no evidence of new or enlarging brain metastases; and the patient does not require any systemic corticosteroids for management of brain metastases within 2 weeks prior to the first dose of study intervention.
E 02 Significant concomitant illnesses, including all severe medical conditions which, in the opinion of the investigator or Sponsor, would impair the patient’s participation in the study or interpretation of the results.
E 03 History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
E 04 History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or active hepatitis A, B (defined as either positive HBs antigen or positive hepatitis B viral DNA test above the lower limit of detection of the assay), or C (defined as a known positive hepatitis C antibody result and known quantitative HCV RNA results greater than the lower limits of detection of the assay) infection. HIV serology at screening will be tested only for participants enrolled in German sites and any countries where mandatory as per local requirements.
E 05 Non-resolution of any prior treatment related toxicity to < Grade 2 according to NCI CTCAE V5.0, except for alopecia, vitiligo and active thyroiditis controlled with hormonal replacement therapy.
E 06 Unresolved corneal disorders or any previous corneal disorder that considered by ophthalmologist that patient may have higher risk of drug induced keratopathy. The use of contact lenses is not permitted. Patients using contact lenses who are not willing to stop wearing them for the duration of the study intervention.
E 07 Medical conditions requiring concomitant administration of medications with narrow therapeutic window, metabolized by CYPs and for which a dose reduction cannot be considered.
E 08. Medical conditions requiring concomitant administration of strong CYP3A inhibitor, unless it can be discontinued at least 2 weeks before first administration of study intervention.
Prior/concomitant therapy
E 09 Concurrent treatment with any other anticancer therapy.
E 10 Prior treatment with docetaxel
E 11 Prior therapy targeting CEACAM5
E 12 Prior maytansinoid treatment (DM1 or DM4 antibody drug conjugate)
E 13 Washout period before the first administration of study intervention of less than 3 weeks or less than 5 times the half-life, whichever is shorter, for prior antitumor therapy
(chemotherapy, targeted agents, immunotherapy and radiotherapy, or any investigational treatment.
E 14 Any major surgery within the preceding 3 weeks of the first study intervention administration.
E 15 Contraindi
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method