A Randomized, Open-Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone In Participants with Advanced Nonsmall Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy (COSTAR Lung)
- Conditions
- Advanced Nonsmall Cell Lung CancerNSCLC10038666
- Registration Number
- NL-OMON56356
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 23
1. Participant is >=18 years old
2. Participant has histologically or cytologically proven advanced or
metastatic NSCLC,
and only squamous or nonsquamous cell carcinoma.
3. Participant has received no more than 2 prior lines of therapy for advanced
or metastatic disease, which must only include a platinum-based doublet
chemotherapy regimen and an anti-PD-(L)1 antibody. Participants previously
treated with targeted therapies, including angiogenesis inhibitors are not
eligible.
a. Two components of treatment must have been received in the same line or as
separate
lines of therapy as follows:
• A maximum of 1 line of therapy containing a platinum-based chemotherapy in the
metastatic setting
and
• A maximum of 1 line of therapy containing an anti-PD-(L)1 antibody
4. Participant has measurable disease, that is, presenting with at least 1
measurable lesion
per RECIST v1.1
5. Participant has documented radiological disease progression on prior
platinum-based
chemotherapy and on prior anti-PD-(L)1 therapy according to RECIST v1.1.
6. Participant agrees to submit an archival FFPE tumor tissue specimen that was
collected
on or after diagnosis of metastatic disease from location(s) not irradiated
prior to biopsy.
7. Participant has documented PD-L1 status by the 22C3 pharmDx assay
(Agilent/Dako), the SP263 assay (Roche) or a LDT with published evidence of
concordance with the 22C3 pharmDx assay. If a prior PD-L1 result by this
testing methods is not available at the time of Screening, the participant must
submit archival or fresh tumor tissue to be tested locally using 1 of these
testing methods, or, if not available, centrally, using the 22C3 pharmDx assay.
8. Participant has an ECOG performance status score of 0 or 1.
9. Participant has a life expectancy of at least 3 months and is anticipated to
be able to complete 4 cycles of docetaxel treatment.
10. Participant has adequate organ function as defined in the protocol.
11. Participant has recovered to Grade <=1 from any prior treatment-related
toxicities at the time of randomization. A participant with Grade 2 alopecia is
an exception to this criterion and may qualify for this study.
12. Contraceptive use by male and female participants should be consistent with
local regulations regarding the methods of contraception for those
participating in clinical
studies.
1. Participant has been previously treated with an anti-PD-(L)1 or anti-PD-L2
agent that resulted in permanent discontinuation due to an AE.
2. Participant has been previously treated with an anti-TIM-3 or anti-CTLA-4
agent or docetaxel.
3. Participant has a documented sensitizing EGFR, ALK, or ROS-1 mutation.
Participants
whose tumors have not been tested for these driver mutations and therefore who
have unknown driver mutation status are not eligible. Participants with
squamous histology do not need to be tested for these driver mutations.
4. Participant had radiological or clinical disease progression <=8 weeks after
initiation of prior
anti-PD-1 or anti-PD-L1 antibody. The clinical disease progression should have
been confirmed by a subsequent radiological scan.
5. Participant has received radiation to the lung that is >30 Gy within 6
months prior to the
first dose of study treatment.
6. Participant has completed palliative radiotherapy within 7 days prior to the
first dose of
study treatment.
7. Participant is ineligible if any of the following hepatic characteristics
are present:
a. Alanine aminotransferase (ALT >2.5×ULN
b. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
>1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP)
>2.5×ULN
c. Bilirubin >1×ULN
d. Current active liver or biliary disease
8. Participant has a corrected QT interval (QTc) >450 msec
9. Participant has had major surgery within 3 weeks prior to the first dose of
study treatment or has not adequately recovered from any AEs (Grade <=1) and/or
complications from any major surgery.
10. Participant has an additional malignancy or a history of prior malignancy,
with the exception of adequately treated basal or squamous skin cancer,
cervical carcinoma in situ, or bladder carcinoma in situ without evidence of
disease, or had a malignancy treated with curative intent and with no evidence
of disease recurrence for 5 years since the initiation of that therapy.
11. Participant has known new or progressive brain metastases and/or
leptomeningeal
metastases.
12. Participant has tested positive for the following at screening or within 3
months before the first dose of the study treatment:
a. presence of hepatitis B surface antigen
b. presence hepatitis C antibody in the absence of an RNA test voor hepatitis C
virus.
13. Participant has an active infection requiring systemic therapy within 1
week prior to the anticipated first dose of study treatment.
14. Participant has known HIV (positive for HIV-1 or HIV-2 antibodies).
15. Participant has active autoimmune disease that required systemic treatment
in the past 2 years, is immunocompromised in the opinion of the Investigator,
or is receiving systemic immunosuppressive treatment.
17. Participant has symptomatic ascites or pleural effusion.
18. Participant has current interstitial lung disease, current pneumonitis, or
a history of pneumonitis that required the use of oral or IV glucocorticoids to
assist with management.
19. Participant has a history or current evidence of any medical condition,
therapy, or laboratory abnormality that might confound the study results,
interfere with participation for the full duration of the study treatment, or
indicate it is not in the best interest
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method