E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer |
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E.1.1.1 | Medical condition in easily understood language |
Lung Cancer or Breast Cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006202 |
E.1.2 | Term | Breast cancer stage IV |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025055 |
E.1.2 | Term | Lung cancer non-small cell stage IV |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To characterize further the safety profile of the combination of abemaciclib and pembrolizumab |
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E.2.2 | Secondary objectives of the trial |
-To characterize further the safety profile of the combination of abemaciclib and pembrolizumab
-To assess the preliminary efficacy of abemaciclib in combination with pembrolizumab
-To characterize the PK of abemaciclib and pembrolizumab when given in combination |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Part A: NSCLC, KRASmt, PD-L1+; Chemotherapy naïve for metastatic NSCLC
Part B: NSCLC, squamous subtype; Must have received only 1 prior therapy containing platinum based chemotherapy for metastatic NSCLC
Part C: HR+, HER2- breast cancer; Must have received at least 1 but no more than 2 chemotherapy regimens for metastatic breast cancer
All patients: amendable to provide tumor tissue prior to treatment and during treatment; ECOG PS <= 1; |
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E.4 | Principal exclusion criteria |
-Have CNS metastasis with associated neurological changes 14 days prior to receiving study drug
-QTc interval of >470msec on screening ECG
-History of interstitial lung disease
-Active autoimmune disease or other syndrome that requires systemic steroids or autoimmune agents for the past 2 years
-Recently treated with an anti-PD-1 or PD-L1 or anti-CTLA-4 agent
-Previously received treatment with any CDK4 or CDK6 inhibitor
-Have history of or current pneumonitis |
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E.5 End points |
E.5.1 | Primary end point(s) |
The safety endpoints per CTCAE v 4.0, NCI 2009 and will include but are not limited to the following:
•TEAEs, ECIs, SAEs, and hospitalizations
•Clinical laboratory tests, vital signs, and physical examinations
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Safety evaluations will occur at each study visit |
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E.5.2 | Secondary end point(s) |
•ORR per tumor assessment using RECIST v1.1 and irRECIST
•PFS rate at 24 weeks per RECIST v1.1 and irRECIST
•DoR per RECIST v1.1 and irRECIST
•DCR per RECIST v1.1 and irRECIST
•OS
Abemaciclib and pembrolizumab concentrations in plasma or serum
Pain and disease-related symptoms assessed by MDASI |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Radiologic assessment is done every 6 weeks for 48 weeks, then every 9 weeks thereafter. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Pain and disease-related symptoms |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Therapeutic Exploratory (Phase 1b) |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
France |
Italy |
Spain |
Taiwan |
Turkey |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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date of the last visit or last scheduled procedure for the last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 20 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 20 |