A Phase II Study of Novel Regimens Versus Standard of Care Treatment in Non-Small Cell Lung Cancer
- Conditions
- on-small cell lung cancer (NSCLC)MedDRA 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
- EUCTR2018-001316-29-DE
- Lead Sponsor
- GlaxoSmithKline Research and Development Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 341
1. Capable of giving signed informed consent/assent as described in Section 12.4 of protocol which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
2. Male or female, aged 18 years or older at the time consent is obtained
Note: Participants in Korea must be age 19 years or older at the time consent is obtained.
3. Histologically or cytologically confirmed diagnosis of NSCLC (squamous or nonsquamous)
and:
a. Documented disease progression (for example, based on radiographic imaging) during or after a maximum of 2 lines of systemic treatment for locally/regionally advanced recurrent, Stage IIIb/Stage IIIc/Stage IV or metastatic disease:
I. No more than or less than 1 line of platinum-containing chemotherapy regimen and
ii. No more than or less than 1 line of PD(L)1 mAb containing regimen.
Notes:
o PD(L)1 mAb received during a previous clinical trial may meet this requirement upon consultation with study medical monitor.
o Participants who received a regimen similar to the PACIFIC regimen [chemoradiotherapy followed by PD(L)1] as part of SoC AND have relapsed within one year from the first dose of chemoradiotherapy would fulfill the protocol requirement for platinum-based chemotherapy treatment and PD-1/L1 treatment. This would be considered a single line of treatment for the purpose of PD(L)1 line of therapy stratification.
o PD(L)1 mAb can be administered with the platinum-based chemotherapy regimen and this would count as a single line of therapy.
o PD(L)1 mAb may be counted as a prior treatment if the agent is approved in at least 1 country for the treatment of cancer.
o Participants who have completed 2 years of pembrolizumab or another PD(L)1 mAb, discontinue from that therapy, experience disease progression, and are then retreated with PD(L)1, will be considered as
having had one line of PD(L)1 therapy.
o Adjuvant or neo-adjuvant systemic anticancer therapy will not count toward the 2 lines of therapy unless disease recurs during the first year following the start of adjuvant chemotherapy.
b. Participants with known BRAF molecular alterations must have had disease progression after receiving the locally available SoC treatment for the molecular alteration.
c.Participants who received prior anti-PD(L)1 therapy must fulfill the
following requirements:
o Have achieved a CR, PR or SD and subsequently had disease
progression (per RECIST 1.1 criteria) either on or after completing
PD(L)1 therapy
o Have not progressed or recurred within the first 12 weeks of PD(L)1
therapy, either clinically or per RECIST 1.1 criteria
4. Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1 (see Appendix 12 of protocol for definition of a measurable lesion)
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
6. A tumor tissue sample obtained at any time from the initial diagnosis of NSCLC to time of study entry is mandatory. Although a fresh tumor tissue sample obtained during screening is preferred, archival tumor specimen is acceptable. See Section 9.9.2 of protocol for further details on tumor tissue requirements.
7. Adequate organ function as defined in Table 2
8. A male participant must agree to use a highly effective contraception
as detailed in Appendix 6 of this protocol during the treatment period
and for at least 120 days after the last dose of study treatment and
refrain from donating sperm during this period.
Note: If the participant
Participants are excluded from the study if any of the following criteria apply:
1. Received prior treatment with the following therapies (calculation is based on date of last therapy to date of first dose of study treatment):
a. Docetaxel at any time
b. Any of the investigational agents being tested in the current study,
refer to Section 12.1 for additional information
c. Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered.
d. Prior radiation therapy: permissible if at least one non-irradiated measurable lesion is available for assessment per RECIST version 1.1
or if a solitary measurable lesion was irradiated, objective progression is documented. A wash out of at least 2 weeks before start of study drug for radiation of any intended use is required.
2.Received >2 prior lines of therapy for NSCLC, including participants with BRAF molecular alterations. (See inclusion criterion #3 for eligible lines of therapy guidance)
Note: Patients with known molecular alterations with therapeutic
options available (e.g., EGFR, ALK, ROS1) are excluded from participation in this study unless no other therapeutic options are
available locally.
3. Invasive malignancy or history of invasive malignancy other than disease under study within the last 2 years, except as noted below:
- Any other invasive malignancy for which the participant was definitively treated, has been disease-free for at least 2 years and in the opinion of the principal investigator and GSK Medical Monitor will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy, may be included in this clinical trial.
- Curatively treated non-melanoma skin cancer or successfully treated situ carcinoma of the skin.
4.Carcinomatous meningitis (regardless of clinical status) and
uncontrolled or symptomatic central nervous system (CNS) metastases.
Note: Participants with previously treated brain metastases may
participate provided they are asymptomatic (any neurologic symptoms
have returned to baseline [participants may be receiving stable doses of
anticonvulsants]), radiographically stable (without evidence of
progression by imaging for at least 4 weeks prior to the first dose of
study treatment), have no evidence of new or enlarging brain
metastases, and are clinically stable off steroids for at least 2 weeks
prior to study treatment.
5. Major surgery =28 days of first dose of study treatment.
6. Autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years. Replacement therapies which include physiological doses of corticosteroids for treatment of endocrinopathies (for example, adrenal insufficiency) are not considered systemic treatments.
Note: Participants with controlled Type 1 diabetes mellitus (T1DM) are eligible.
7. Receiving systemic steroids (>10 mg oral prednisone or equivalent) or other immunosuppressive agents within 7 days prior to first dose of study treatment.
Note: Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication) are permitted. Use of
inhaled corticosteroids, local steroid injection, or steroid eye drops is allowed.
8. Prior allogeneic/autologous bone marrow or solid organ transplantation.
9. Receipt of any live vaccine within 30 days
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