Study of ALRN-6924, for the Prevention of Chemotherapy-induced Myelosuppressio
- Conditions
- Small Cell Lung Cancer and Non small cell lung cancerMedDRA version: 21.1Level: PTClassification code 10041067Term: Small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)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
- EUCTR2019-001848-21-PL
- Lead Sponsor
- Aileron Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 136
SCLC
1.Males and females age 18 years or older.
2.Ability to understand the requirements of this clinical trial and willingness to provide written informed consent
3.Histopathological confirmation of ED SCLC that has recurred or been refractory to one line of treatment with standard platinum-based chemotherapy or immuno-chemotherapy. Patients who received immunotherapy after platinum-based chemotherapy remain eligible.
4.Mutated TP53: no wild type (WT) TP 53 gene copies within the tumor (i.e., biallelic mutation, biallelic deletion, or mutation/deletion), as assessed by next generation sequencing (NGS)
5.Measurable disease using RECIST 1.1
6.Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
7.Adequate hematological status:
a.absolute neutrophil count (ANC) =1500/?L
b.platelet count =100,000/?L
c.hemoglobin =9.0 g/dL
8.Adequate hepatic and renal function:
a.total bilirubin =1.5 X upper limit of normal (ULN) or = 3 X ULN in the presence of Gilbert syndrome or liver metastases
b.alkaline phosphatase (ALP), aspartate aminotransferase (AST [SGOT]), and alanine aminotransferase (ALT [SGPT]) = 2.5 X ULN in the absence of liver metastases
c.ALP, AST (SGOT), and ALT (SGPT) =5 X ULN in the presence of liver metastases
d.serum creatinine <1.5 X ULN or calculated creatinine clearance = 40 mL/min (C&G or EDTA)
9.Recovery from the acute toxic effects of all prior therapies to Grade =1
10.The shorter of 5 half-lives or 4 weeks must have elapsed since any prior systemic therapy, unless no drug-drug interactions with study treatment would be anticipated and the patient had unequivocal radiologic disease progression during the prior line of therapy.
11.Males and female patients of child-bearing potential must agree to use an acceptable method of birth control for the duration of study treatment and for 3 months (male patients with female partner of child-bearing potential) or 6 months (female patients of child-bearing potential) following the last dose of study treatment.
NSCL
1.Males and females age 18 years or older.
2.Ability to understand the requirements of this clinical trial and willingness to provide written informed consent.
3.Histopathological confirmation of Stage IV NSCLC of adenocarcinoma histology. Cytological diagnosis of NSCLC is acceptable if sufficient tumor tissue is available for p53 mutation analysis. FDA approved liquid biopsies are also acceptable.
4.Presence of p53 mutation(s) in tumor tissue or circulating cell free DNA as assessed by next generation sequencing (NGS).
5.Patients who are deemed to be good candidates for chemotherapy with carboplatin and pemetrexed, OR standard immunochemotherapy that includes carboplatin and pemetrexed, with a planned delivery of at least 4 chemotherapy treatment cycles. Concurrent use of bevacizumab as per local treatment practice, is permitted.
6.No prior systemic therapy for any stage NSCLC, including chemotherapy, immunotherapy or targeted drugs (e.g., inhibitors of EGFR, ALK, ROS, RET, HER2, BRAF etc.).
7.Absence of tumor genomic aberrations of EGFR, ALK or other actionable genomic aberrations, as per local standard of care.
8.Measurable disease using RECIST 1.1
9.Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
10.Adequate hematological status without supportive care measures during screening period:
a.ANC =1500/mL
b.platelet count =100,000/mL
hemoglobin =9.0 g/dL
11.Adequate hepatic and renal function:
a.total bilirubin =
SCLC
1.Known hypersensitivity to any component of study treatment.
2. Presence of active and symptomatic central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable, with no evidence of radiographic or neurologic progression during the screening period and no requirement for steroids for at least 15 days before enrolment.
3. Advanced NSCLC tumors with EGFR mutations or ALK re-arrangement or other actionable genetic aberrations for which an approved targeted treatment is available. Patients who received prior treatment with EGFR or ALK inhibitors or other systemic drugs or immunotherapy for NSCLC are not eligible for participation.
4. Patients who are candidates for anti-PD-1 monotherapy in 1stline advanced NSCLC (e.g., tumors with high PD-L1 expression).
5. Patients who received prior systemic treatment for earlier stage NSCLC disease other than surgery, immunotherapy and/or localized radiotherapy. Patients who received neoadjuvant or adjuvant chemotherapy, or radiochemotherapy are not eligible for participation.
6. Uncontrolled intercurrent illness including but not limited to:
a. Clinically significant, active, uncontrolled infection including human immunodeficiency virus (HIV), or hepatitis B or C
i. Patients with HIV must be on effective antiretroviral therapy for = 4 weeks prior to enrollment and have HIV viral load < 400 copies/mL, have had no acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the past 12 months, and have CD4+ count = 350 cells/µL.
ii. Patients with chronic hepatitis B virus (HBV) must be on antiviral therapy and have HBV viral load below the limits of detection.
iii. Patients with hepatitis C virus (HCV) must be on or have completed antiviral therapy and have an HCV viral load below the limits of detection.
b. Uncontrolled hypertension
c. Uncontrolled diabetes mellitus
7. Serum albumin <30 g/L
8. Clinically significant electrolyte abnormalities
9. Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker
10. History of prior malignancy; patients with a known malignancy that does not affect overall well-being and ability to participate in the study can be considered in consultation with the Medical Monitor. see more exclusion criteria in the protocol
NSCL
Exclusion Criteria:
1.Known hypersensitivity to any component of study treatment.
2.Presence of active and symptomatic central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable, with no evidence of radiographic or neurologic progression during the screening period and no requirement for steroids for at least 15 days before enrolment.
3.Advanced NSCLC tumors with EGFR mutations or ALK re-arrangement or other actionable genetic aberrations for which an approved targeted treatment is available. Patients who received prior treatment with EGFR or ALK inhibitors or other systemic drugs or immunotherapy for NSCLC are not eligible for participation.
4.Patients who are candidates for anti-PD-1 monotherapy in 1st-line advanced NSCLC (e.g., tumors with high PD-L1 expression).
5.Patients who received prior systemic treatment for earlier stage NSCLC disease other than surgery, immunotherapy and/or localized r
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