A phase 3 study evaluating ociperlimab plus tislelizumab versus durvalumab
- Conditions
- ocally Advanced, Unresectable, PD L1 Selected Non- Small Cell Lung Cancer Where Disease Has Not Progressed After Concurrent ChemoradiotherapyMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-004656-14-DE
- Lead Sponsor
- BeiGene, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 700
1. Age = 18 years on the day of signing the ICF (or the legal age of
consent in the jurisdiction in which the study is taking place).
2. Ability to provide written informed consent and to understand and
agree to comply with the requirements of the study and the schedule of
assessments.
3. Patient has histologically or cytologically confirmed, locally advanced,
unresectable Stage III NSCLC (AJCC Cancer Staging Manual 2017,
derived from IASLC) prior to initiation of cCRT.
4. Patients must have completed at least 2 cycles of platinum-based
chemotherapy concurrent with radiotherapy. For patients who are
recovering from toxicities associated with prior treatment, the first dose
of study treatment may be delayed by up to 42 days from the end of the
cCRT. It is recommended to screen the patients within 14 days after the
completion of cCRT.
a. The platinum-based chemotherapy regimen must contain cisplatin or
carboplatin, and may contain one of the following agents: etoposide,
vinblastine, vinorelbine, taxane (paclitaxel or docetaxel), or pemetrexed,
according to the local standard of care regimens. If a patient was
receiving a weekly chemotherapy regimen, platinum-based
chemotherapy of at least 4 weeks should be completed.
b. The last dose of chemotherapy must be administered no later than the
last dose of radiotherapy. Consolidation chemotherapy is not allowed
after radiotherapy; but induction chemotherapy no more than 2 cycles
before cCRT is allowed.
c. Where possible, chemotherapy regimens should be given according to
National Comprehensive Cancer Network (NCCN) Guidelines, European
Society for Medical Oncology (ESMO) Guidelines, Chinese Society of
Clinical Oncology (CSCO) Guidelines, Japan Lung Cancer Society (JLCS)
Guidelines, or other local guidelines if applicable.
d. Patients must have received a total dose of radiation of 60 ± 10% Gy
(54 to 66 Gy), as part of the CRT.
e. The minimum technical standard for radiotherapy is 3D conformal
radiotherapy (3D CRT) with CT planning. Intensity modulated
radiotherapy (IMRT) is recommended.
f. RT dose received by organs is recommended to be (the medical
monitor needs to be consulted to confirm eligibility for the patients who
received higher RT dose for the organs below):
• Spinal cord: max dose = 48 Gy
• Lung: V20 = 35%, mean dose = 20 Gy
• Esophagus: mean dose = 34Gy
• Heart: V50 = 25%, mean dose = 20 Gy
5. Patients must have not experienced PD following definitive, platinum
based cCRT.
6. Agree to provide archival tissue (formalin-fixed paraffin-embedded
block containing tumor [preferred] or approximately 6 to 15 freshly cut
unstained slides) or fresh biopsy obtained prior to cCRT (if archival
tissue is not available) for prospective central evaluation of PD-L1 levels
and retrospective analysis of other biomarkers. PD-L1 status will be
assessed centrally in either a previously obtained archival tumor tissue
or fresh tissue obtained from a biopsy collected prior to the first dose of
cCRT via VENTANA PD L1 (SP263) assay. Only patients with PD L1 = 1%
of TC are eligible.
7. ECOG Performance Status of 0 or 1.
8. Patients must have adequate organ function as indicated by the following screening laboratory values obtained within 7 days before
randomization:
a. Patients must not have required blood transfusion or growth factor
support = 14 days before sample collection at screening for the
following:
i. Absolute neutrophil count (ANC) = 1.5 x 109/L
ii. Platelets = 75 x 109/L
iii. Hemoglobin = 90 g/L o
1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT, or any
other antibody or drugs specifically targeting T-cell co-stimulation or
checkpoint pathways.
2. Diagnosed with NSCLC that harbors an EGFR-sensitizing mutation, ALK
gene translocation, ROS1 gene translocation or RET gene
rearrangement.
a. For nonsquamous and squamous NSCLC, patients with known EGFR
mutation status, ALK translocation, ROS1 translocation, or RET
rearrangement who are sensitive to available targeted inhibitor therapy
are excluded.
b. For nonsquamous NSCLC, patients with unknown EGFR mutation
status will be required to undergo a tissue-based EGFR test locally or at
a central laboratory before randomization. An additional = 6 slides are
required if EGFR mutation status needs to be tested in a central
laboratory. Patients with sensitive EGFR mutation status will be
excluded. Patients with unknown ALK, ROS1, or RET status may be
enrolled.
c. Patients with squamous NSCLC and unknown EGFR, ALK, ROS1, or RET
status will not be required to be tested before randomization.
3. Distant metastasis identified by imaging assessment and/or other
examinations after definitive, platinum-based cCRT.
4. Patients who received chemotherapy and radiotherapy with = 1 cycle
overlap for LA NSCLC.
5. Patients who received systemic anticancer treatment besides the
specified cCRT.
6. Any unresolved toxicity CTCAE > Grade 2 from the prior cCRT. Patients
with irreversible toxicity that is not reasonably expected to be
exacerbated by study treatment may be included (eg, hearing loss).
7. Patients with any grade pneumonitis from prior cCRT.
8. Active autoimmune diseases or history of autoimmune diseases that
may relapse. Note: Patients with the following diseases are not excluded
and may proceed to further screening:
a. Controlled Type I diabetes.
b. Hypothyroidism (provided it is managed with hormone replacement therapy only).
c. Controlled celiac disease.
d. Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis,
alopecia).
e. Any other disease that is not expected to recur in the absence of
external triggering factors.
9. Any active malignancy = 2 years before the first dose of study
treatment except for the specific cancer under investigation in this study
and any locally recurring cancer that has been treated curatively (eg,
resected basal or squamous cell skin cancer, superficial bladder cancer,
carcinoma in situ of the cervix or breast).
10. Any condition that required systemic treatment with either
corticosteroids (> 10 mg daily of prednisone [in Japan, prednisolone] or
equivalent) or other immunosuppressive medication = 14 days before
the first dose of study treatment.
Note: Patients who are currently or have previously been on any of the
following steroid regimens are not excluded:
a. Adrenal replacement steroid (dose = 10 mg daily of prednisone [in
Japan, prednisolone] or equivalent).
b. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid
with minimal systemic absorption.
c. Short course (= 7 days) of corticosteroid prescribed prophylactically
(eg, for contrast dye allergy) or for the treatment of a non-autoimmune
condition (eg, delayed-type hypersensitivity reaction caused by contact
allergen.
11. Uncontrolled diabetes or > Grade 1 laboratory test abnormalities in
potassium, sodium, or corrected calcium despite standard medical
management or = Grade 3 hypoalbuminemia = 14 days before the first
dose of study treatment.
12. Uncontrollab
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method