Advanced or Metastatic Non-Small Cell Lung Cancer MedDRA version: 21.1 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Infliximab
Product Code: [NA]
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
Current Sponsor code: NA
Concentration unit: mg millig
Sponsors
ASTRAZENECA AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant must be >= 18 years at the time of screening. 2. Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology. 3. Documented EGFR and ALK wild-type status as determined at a local laboratory. 4. Documented radiological PD whilst on or after receiving the most recent treatment regimen. 5. Eligible for second- or third-line therapy and must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC either separately or in combination. 6. ECOG/WHO performance status of 0 or 1. 7. Adequate organ function and marrow reserve 8. Minimum life expectancy of 12 weeks. 9. Body weight > 30 kg and no cancer-associated cachexia. 10. Negative pregnancy test (serum test) for WOCBP. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 320 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 260
Exclusion criteria
Exclusion criteria: 1. Participant with mixed SCLC and NSCLC histology. 2. History of another primary malignancy except for malignancy treated with curative intent with no known active disease >= 5 years before the first dose of study intervention. 3. Persistent toxicities (CTCAE Grade > 2) caused by previous anticancer therapy. 4. Active or prior documented autoimmune or inflammatory disorders. 5. Participants who have received more than one line of prior anti-PD- (L)1, either alone or in any combination. 6. Participants: (a) Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy. (b) All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved. (c) Must not have experienced a Grade >= 3 imAE or an immune-related neurologic or ocular AE of any grade while receiving prior anti-PD(L)1 therapy. (d) Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day. 7. Participants who have received more than one prior line of platinum- based chemotherapy in metastatic setting. 8. Participants who have received a prior ATR inhibitor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superiority of ceralasertib plus durvalumab combination therapy relative to docetaxel by assessment of OS in participants with advanced NSCLC after second- or thirdline therapy and without actionable genomic alterations;Secondary Objective: - To demonstrate superiority of ceralasertib plus durvalumab (C&D) combination therapy relative to docetaxel by assessment of PFS. - To estimate the effectiveness of C&D combination therapy relative: • to docetaxel by assessment of ORR • to docetaxel by assessment of duration of response (DoR) • to docetaxel by assessment of time to response (TTR) • to docetaxel by assessment of disease control rate (DCR) at 18 weeks • to docetaxel by assessment of time to second progression or death (PFS2) • to docetaxel by assessment of OS at 12 months (OS12) -To assess participant-reported health-related quality of life (QoL) - To assess participant-reported physical functioning in participants treated with C&D combination therapy relative to docetaxel PLEASE REFER TO THE PROTOCOL FOR FURTHER DETAILS;Primary end point(s): - OS is defined as time from randomisation until the date of death due to any cause. - The comparison will include all randomised participants, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy. - The measure of interest is the HR of OS.;Timepoint(s) of evaluation of this end point: Time from randomisation until the date of death due to any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To demonstrate superiority of ceralasertib plus durvalumab relative to docetaxel by assessment of PFS, ORR, of duration of response (DoR), time to response (TTR), disease control rate (DCR) at 18 weeks, time to second progression or death (PFS2), OS at 12 months (OS12), participant-reported health-related quality of life (QoL), participant- reported physical functioning, participant-reported treatment tolerability. - To assess the PK of ceralasertib when administered in combination with durvalumab. - To assess safety and tolerability of ceralasertib plus durvalumab therapy as compared with docetaxel;Timepoint(s) of evaluation of this end point: - The tumour response endpoints (PFS, ORR, DoR and TTR) will be driven from randomisation up until progression, or the last evaluable assessment in the absence of progression (up to three years). -Plasma concentration of ceralasertib and sparse PK parameters such as peak concentration and trough, as data allow. - Safety and tolerability will be evaluated in terms of TEAEs, vital signs, clinical laboratory results, and ECGs | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Republic of, Netherlands, Poland, Romania, Serbia, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Study Information Center
AstraZeneca AB
Outcome results
None listed