Status:
TERMINATED
Durvalumab Followed by Chemoradiation and Consolidation Durvalumab for Stage III Non-small Cell Lung Cancer
Lead Sponsor:
Rachel Sanborn
Collaborating Sponsors:
AstraZeneca
Providence Cancer Center, Earle A. Chiles Research Institute
Conditions:
Lung Cancer
Non-small Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Single arm study of induction durvalumab (1500 mg IV) for 1 cycle (every 4 weeks), administered prior to starting concurrent definitive chemoradiation, followed by consolidation durvalumab (1500 mg IV...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0 or 1.
- Histological or cytological confirmation of stage III non-small cell lung cancer per AJCC, 8th edition, eligible for curative-intent concurrent chemoradiation. NOTE: subjects are not candidates for surgical resection either due to medical inoperability or surgically unresectable disease.
- Measurable disease according to RECIST 1.1 criteria.
- Plan for treatment with concurrent chemoradiation with a dose of radiation ranging from 54-66 Gy:
- Planned mean dose delivery to the lung \<20 Gy
- V20 \<35%
- No prior therapy for stage III NSCLC.
- Demonstrate adequate organ function as defined in the protocol. All screening labs to be obtained within 14 days prior to registration.
- Females of childbearing potential must have a negative serum pregnancy test within 24 hours of C1D1. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months.
- Females of childbearing potential must be willing to abstain from heterosexual intercourse or to use contraception as outlined in the protocol.
- Men who are sexually active with WOCBP must be willing to abstain from heterosexual intercourse or to use contraception as outlined in the protocol.
- Life expectancy of at least 12 weeks per investigator discretion.
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
- Exclusion Criteria
- Subjects meeting any of the criteria below may not participate in the study:
- Prior therapy for stage III NSCLC
- Mixed histology with small cell lung cancer will not be allowed.
- Sequential chemoradiation will not be permitted.
- Induction and consolidation chemotherapy (separate from concurrent chemoradiation) will not be allowed.
- Prior exposure to anti-PD-1 or anti-PD-L1 antibodies including durvalumab.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed \<\<10 mg/day\>\> of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- History of pulmonary fibrosis, interstitial lung disease, or pneumonitis requiring steroids.
- Active or prior documented autoimmune disease within the last 2 years. Patients with vitiligo, stable hypothyroidism, Grave's disease, or psoriasis not requiring systemic treatment are not excluded.
- Body weight \< 30 kg
- Active and ongoing steroid use, except for non-systemically absorbed treatments (such as inhaled or topical steroid therapy for asthma, COPD, allergic rhinitis).
- Active infection requiring systemic therapy.
- Uncontrolled current illness that in the opinion of the investigator renders the investigational treatment plan unsafe.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. NOTE: Local surgery of isolated lesions for palliative intent is acceptable.
- Active other malignancy; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer.
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Treatment with any investigational drug within 30 days prior to registration.
- History of organ transplantation (including allogeneic stem cell transplantation).
- Other medical or psychiatric conditions that in the opinion of the site investigator would preclude safe participation in this protocol.
- Eligibility Criteria for Consolidation Durvalumab
- Patients must have recovered from toxicities associated with prior chemoradiation to CTCAE \< Grade 2.
- Patients must not have progressed following chemoradiation therapy, as measured on imaging per RECIST 1.1.
- Confirmation of ECOG Performance Status of 0 or 1.
- Any grade pneumonitis from prior chemoradiation will not be permitted.
Exclusion
Key Trial Info
Start Date :
June 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04364048
Start Date
June 18 2020
End Date
February 5 2024
Last Update
December 20 2024
Active Locations (5)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612
2
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
3
HealthPartners Institute
Minneapolis, Minnesota, United States, 55440
4
Summit Medical Group, P. A.
Berkeley Heights, New Jersey, United States, 07922