The aim of this study is to determine if the Investigational Medicinal Product Tedopi
(OSE2101) is more effective than standard treatment in treating patients with stage IIIB
NSCLC unsuitable for radiotherapy or metastatic NSCLC in second- or third-line treatment
after failure of immune checkpoint-inhibitor regimens.
1. Signed and dated informed consent document indicating that the patient has been
informed of all the pertinent aspects of the trial prior to enrollment.
2. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures.
3. Female or male, 18 years of age or older.
4. Histologically or cytologically proven diagnosis of NSCLC that is locally advanced
(stage IIIB) unsuitable for radiotherapy or metastatic (stage IV) according to the 7th
edition of tumor, node, metastasis (TNM) in Lung Cancer published by the International
Union Against Cancer and the American Joint Committee on Cancer.
5. Subjects with disease recurrence or progression After therapy with an immune
checkpoint inhibitor and platinum-based chemotherapy i) either 1st line chemotherapy
followed by 2nd line checkpoint inhibitor, or ii) 1st line combination of checkpoint
inhibitor and chemotherapy
6. Subjects with measurable or non-measurable lesions.
7. Subjects must express HLA-A2 phenotype as assessed serologically.
8. Subjects must be considered suitable for chemotherapy with either single-agent
pemetrexed or docetaxel.
9. Subjects with brain metastases are eligible if treated (whole brain radiotherapy,
stereotaxic radiotherapy, surgery) and have no symptoms (except for signs and symptoms
related to central nervous system therapy) for at least 2 weeks before initiation of
allocated treatment and are not taking any forbidden medications.
10. Any prior chemotherapy, immunotherapy, radiation therapy or surgeries must have been
completed at least 3 weeks prior to initiation of study medication.
11. Any toxicity from prior therapy must have recovered to ≤ Grade 1 (except alopecia).
12. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
13. Adequate organ function as defined by all the following criteria:
- Albuminemia > 25g/L
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 1.5 x
upper limit of normal (ULN) with alkaline phosphatase ≤ 2.5 x ULN, or AST and ALT
≤ 5 x ULN if liver function abnormalities are due to liver metastases
- Total serum bilirubin ≤ 1.5 x ULN
- Absolute neutrophil count (ANC) ≥ 1500/L
- Platelets ≥ 100000/L
- Hemoglobin ≥ 9.0 g/dL (in the absence of transfusion within 2 weeks before
- Creatinine clearance (based on modified Cockcroft-Gault formula) ≥ 45 ml/min.
1. Small-cell lung cancer/mixed NSCLC with small cell component or other neuroendocrine
lung cancers (typical and atypical carcinoids, large-cell neuroendocrine carcinomas).
2. NSCLC that is predominantly squamous cell carcinoma, and patient had docetaxel as part
of his prior chemotherapy.
3. Current or previous treatment with investigational therapy in another therapeutic
clinical trial interrupted less than 4 weeks before study treatment initiation.
4. Patients whose tumor harbors EGFR gene mutation that sensitizes tumors to
Tyrosine-Kinase Inhibitor (TKI) (EGFR exon 18-21) or Anaplastic Lymphoma Kinase (ALK)
5. Ongoing immunotherapy (checkpoint inhibition, antigen immunotherapy that would be
scheduled to continue concomitantly to the study).
6. Spinal cord compression (unless treated with the patient attaining good pain control
and stable or recovered neurologic function), carcinomatous meningitis, or
7. Patients with squamous cell histology or non-squamous cell histology previously
treated by pemetrexed and with a contraindication for docetaxel with grade ≥ 2
neuropathy or hypersensitivity reaction to medications formulated with polysorbate 80
(Tween 80) as they could be randomly assigned to Arm B.
8. Patients with a condition requiring systemic treatment with either corticosteroids or
other immunosuppressive medications.
9. Treatment with corticosteroids in the last 3-week period before inclusion, except for
topical, ocular, intra-articular, intranasal, and inhaled corticosteroids with minimal
systemic absorption (e.g. with a dose ≤ 500 microgram beclomethasone equivalent for
inhaled steroids), or adrenal replacement steroid doses ≤ 10 mg daily prednisone
equivalent which are permitted.
10. A recognized immunodeficiency disease including human immunodeficiency virus (HIV)
infection (and other cellular immunodeficiencies, hypogammaglobulinemia or
dysgammaglobulinemia; subjects who have hereditary, congenital or acquired
11. Patients with auto-immune disease, with the exception of type I diabetes or treated
12. Patients with interstitial lung disease.
13. Patients with active B or C hepatitis.
14. Other malignancy: patients will not be eligible if they have evidence of active
malignancy (other than non-melanoma skin cancer or localized cervical cancer, or
localized and presumed cured prostate cancer).
15. Other severe acute or chronic medical or psychiatric conditions, or laboratory
abnormalities that would impart, in the judgment of the investigator and/or sponsor,
excess risk associated with study participation or study drug administration, and
which would, therefore, make the patient inappropriate for entry into this study.
16. Female patients must be surgically sterile or be postmenopausal, or must agree to use
effective contraception during the period of the trial and for at least 90 days after
completion of treatment.
17. Male patients sexually active with a woman of childbearing potential must be
surgically sterile or must agree to use effective contraception during the period of
the trial and for at least 90 days after completion of treatment. The decision of
effective contraception will be based on the judgment of the principal investigator.
18. Breastfeeding women.
19. Women with a positive pregnancy test.