Non small cell lung cancer with a Her2 mutation MedDRA version: 21.1 Level: PT Classification code 10029519 Term: Non-small cell lung cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 23.0 Level: PT Classification
Conditions
Interventions
Trade Name: Perjeta
Product Name: Pertuzumab
Product Code: RO4368451
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PERTUZUMAB
CAS Number: 380610-27-5
Current Sponsor
Sponsors
IFCT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient having signed an informed consent form 2. Histologically or cytologically confirmed NSCLC (per 2015 8th edition TNM classification) 3. Not suitable for radiation, inoperable stage III or stage IV 4. HER2 exon 20 mutation or insertion among which: in-frame insertions in exon 20 between codons 775 and 881 including the 12bp insertion with a duplication / insertion of 4 amino acids (YVMA) at codon 775, the 3bp insertion with a complex insertion-substitution G776>VC and point mutations L755S and G776C. Other mutation/insertion should be discussed with IFCT. Analysis must be performed in INCa-labelled laboratories or platforms according to a validated procedure. 5. Prior treatment with at least one regimen of platinum-based chemotherapy with documented disease progression. Note: taxanes are allowed provided that no grade >2 associated adverse event occurred (except hematological toxicity). 6. Presence of at least one lesion that can be measured by CT scan (RECIST v1.1) 7. Age = 18 years 8. Adequate organ function, as evidenced by the following laboratory results: ANC > 1500 cells/mm3 Platelet count > 100,000 cells/mm3 Hemoglobin > 9.0 g/dL Patients are allowed to receive transfused RBC to achieve this level. Total bilirubin = 1.5 × ULN, except in patients with previously documented Gilbert’s syndrome, in which case the direct bilirubin should be less than or equal to the ULN SGOT and SGPT = 2.5 × ULN Alkaline phosphatase = 2.5 × ULN, Alkaline phosphatase 3 months 13. A female is eligible to enter and participate in this study if she is of: Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has undergone: • Hysterectomy. • Bilateral oophorectomy (ovariectomy). • Bilateral tubal ligation. • Or who is post-menopausal: • Patients not using hormone replacement therapy (HRT) must have experienced total cessation of menses for =1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone value >40 mIU/mL and an estradiol value <40 pg/mL (<140 pmol/L). • Patients must discontinue HRT prior to study enrolment due to the potential for inhibition of cytochrome enzymes that metabolize estrogens and progestins. For most forms of HRT, at least 2 4 weeks must elapse between the cessation of HRT and determination of menopausal status; length of this interval depends on the type and dosage of HRT. If a female subject is determined not to be post-menopausal, they must use adequate contraception, as defined immediately below. Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception during the study and for at least 7 months after the last dose of investigational product. Contraceptive methods acceptable to IFCT, when used consistently and in accordance with
Exclusion criteria
Exclusion criteria: 1. History of cancer except cancer dating from over two years ago and considered to be cured, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma and stage I uterine cancer. 2. Any approved anti-cancer therapy = 21 days before enrollment. Note: TKIs approved for the treatment of NSCLC must be discontinued = 7 days prior to the first study treatment on Cycle 1, Day 1. (The baseline scan must be completed after discontinuation of TKIs). 3. Patients with concomitant EGFR, ALK, ROS1, MET, BRAF and KRAS mutation. Other molecular co-alterations should be discussed with IFCT before patient’s enrollment. 4. Previous treatment with an anti-HER2 agent. 5. Any other investigational therapy = 28 days before inclusion 6. Previous irradiation 2 from previous anti-tumor treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of trastuzumab in combination with pertuzumab and docetaxel in patients with HER2 mutated advanced NSCLC;Secondary Objective: - Confirmed Objective response rate (ORR) at 6 weeks - Progression-Free Survival (PFS) - Duration of response - Overall survival - Safety ;Primary end point(s): Overall response;Timepoint(s) of evaluation of this end point: This event could occur at any point during the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Confirmed Objective Response Rate at 6 weeks (ORR) - Progression-Free Survival (PFS) - Duration of response - Overall survival - Safety ;Timepoint(s) of evaluation of this end point: - 6w, confirmed at least after 4w - Time from enrollment until death due to any cause. For patients who do not die, time to death will be censored at the time of last contact. - Time from enrollment to first observation of progression (according to RECIST v1.1) or date of death (from any cause). Patients who did not progress or not die will be censored on the date of their last tumor assessment, i.e. on the last date that we really know that the patient was progression free. - Time from documentation of tumor response to disease progression. Patients who did not progress will be censored on the date of their last tumor assessment, i.e. on the last date that we really know that the patient was progression free. - Safety will be measured by the incidence, nature, and severity of AEs. | — |
Countries
France
Contacts
Public ContactContact
IFCT
Outcome results
None listed