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JOURNAL ONKOLOGIE – STUDIE

LIBRETTO-431 A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Rekrutierend

NCT-Nummer:
NCT04194944

Studienbeginn:
Dezember 2019

Letztes Update:
21.02.2021

Wirkstoff:
Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Eli Lilly and Company

Collaborator:
Loxo Oncology, Inc. a wholly owned subsidiary of Eli Lilly and Company

Studienleiter

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Study Director
Eli Lilly and Company

Kontakt

There will be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Kontakt:
Phone: 1-317-615-4559
E-Mail: ClinicalTrials.gov@lilly.com
» Kontaktdaten anzeigen

Studienlocations (3 von 214)

Centro Paulista de Oncologia
04538-133 São Paulo
BrazilRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The reason for this study is to see if the study drug selpercatinib compared to a standard

treatment is effective and safe in participants with rearranged during transfection (RET)

fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other

parts of the body. Participants who are assigned to the standard treatment and discontinue

due to progressive disease have the option to potentially crossover to selpercatinib.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically or cytologically confirmed, Stage IIIB-IIIC or Stage IV non-squamous

NSCLC that is not suitable for radical surgery or radiation therapy.

- A RET gene fusion in tumor and/or blood from a qualified laboratory.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

- Adequate hematologic, hepatic and renal function.

- Willingness of men and women of reproductive potential to observe conventional and

highly effective birth control for the duration of treatment and for 6 months after.

- Ability to swallow capsules.

Exclusion Criteria:

- Additional validated oncogenic drivers in NSCLC if known.

- Prior systemic therapy for metastatic disease. Treatment (chemotherapy, immunotherapy,

or biological therapy) in the adjuvant/neoadjuvant setting is permitted if it was

completed at least 6 months prior to randomization.

- Major surgery within 3 weeks prior to planned start of selpercatinib.

- Radiotherapy for palliation within 1 week of the first dose of study treatment or any

radiotherapy within 6 months prior to the first dose of study treatment if more than

30 Gy to the lung.

- Symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or

untreated spinal cord compression.

- Clinically significant active cardiovascular disease or history of myocardial

infarction within 6 months prior to planned start of selpercatinib or prolongation of

the QT interval corrected for heart rate using Fridericia's formula (QTcF) > 470

milliseconds.

- Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing

intercurrent illness, such as hypertension or diabetes, despite optimal treatment.

- Clinically significant active malabsorption syndrome or other condition likely to

affect gastrointestinal absorption of the study drug.

- Pregnancy or lactation.

- Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or

other in situ cancers or a malignancy diagnosed ≥2 years previously and not currently

active.

- Uncontrolled, disease related pericardial effusion or pleural effusion.

- Requiring chronic treatment with steroids.

Exclusion Criteria for Participants Receiving Pembrolizumab:

- History of interstitial lung disease or interstitial pneumonitis.

- Active autoimmune disease or any illness or treatment that could compromise the immune

system.

Studien-Rationale

Primary outcome:

1. Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (with Pembrolizumab) (Time Frame - Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months)):
PFS by BICR (with Pembrolizumab)

2. PFS by BICR (with or without Pembrolizumab) (Time Frame - Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months)):
PFS by BICR (with or without Pembrolizumab)

Secondary outcome:

1. Disease Control Rate (DCR) by BICR (with Pembrolizumab) (Time Frame - Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months)):
DCR by BICR (with Pembrolizumab)

2. DCR by BICR (with or without Pembrolizumab) (Time Frame - Baseline to Progressive Disease or Death from Any Cause (Estimated at up to 24 Months)):
DCR by BICR (with or without Pembrolizumab)

3. PFS2 (with Pembrolizumab) (Time Frame - Baseline to Second Disease Progression or Death from Any Cause (Estimated at up to 36 Months)):
PFS2 (with Pembrolizumab)

4. PFS2 (with or without Pembrolizumab) (Time Frame - Baseline to Second Disease Progression or Death from Any Cause (Estimated at up to 36 Months)):
PFS2 (with or without Pembrolizumab)

5. Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) by BICR (with Pembrolizumab) (Time Frame - Baseline through Disease Progression or Death (Estimated at up to 24 Months)):
ORR: Percentage of Participants with CR or PR by BICR (with Pembrolizumab)

6. ORR: Percentage of Participants with CR or PR by BICR (with or without Pembrolizumab) (Time Frame - Baseline through Disease Progression or Death (Estimated at up to 24 Months)):
ORR: Percentage of Participants with CR or PR by BICR (with or without Pembrolizumab)

7. Duration of Response (DoR) by BICR (with Pembrolizumab) (Time Frame - Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated at up to 24 Months)):
DOR by BICR (with Pembrolizumab)

8. DOR by BICR (with or without Pembrolizumab) (Time Frame - Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated at up to 24 Months)):
DOR by BICR (with or without Pembrolizumab)

9. Overall Survival (OS) (with Pembrolizumab) (Time Frame - Baseline to Date of Death from Any Cause (Estimated at up to 48 Months)):
OS (with Pembrolizumab)

10. OS (with or without Pembrolizumab) (Time Frame - Baseline to Date of Death from Any Cause (Estimated at up to 48 Months)):
OS (with or without Pembrolizumab)

11. Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 by BICR (with Pembrolizumab) (Time Frame - Baseline through Central Nervous System (CNS) Progression or Death (Estimated at up to 24 Months)):
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with Pembrolizumab)

12. Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with or without Pembrolizumab) (Time Frame - Baseline through CNS Progression or Death (Estimated at up to 24 Months)):
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with or without Pembrolizumab)

13. Intracranial DOR per RECIST 1.1 by BICR (with Pembrolizumab) (Time Frame - Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause (Estimated at up to 24 Months)):
Intracranial DOR per RECIST 1.1 by BICR (with Pembrolizumab)

14. Intracranial DOR per RECIST 1.1 by BICR (with or without Pembrolizumab) (Time Frame - Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause (Estimated at up to 24 Months)):
Intracranial DOR per RECIST 1.1 by BICR (with or without Pembrolizumab)

15. Time to Deterioration of Pulmonary Symptoms (with Pembrolizumab) (Time Frame - Baseline to Deterioration of Pulmonary Symptoms (Estimated at up to 24 Months)):
Time to Deterioration of Pulmonary Symptoms Measured by the NSCLC-Symptom Assessment Questionnaire (SAQ) (with Pembrolizumab)

16. Time to Deterioration of Pulmonary Symptoms (with or without Pembrolizumab) (Time Frame - Baseline to Deterioration of Pulmonary Symptoms (Estimated at up to 24 Months)):
Time to Deterioration of Pulmonary Symptoms Measured by the NSCLC-SAQ (with or without Pembrolizumab)

17. The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants with RET-Positive Specimens as Called by the Central Lab, which is also RET-Positive as Called by a Local Lab (Positive Percent Agreement) (Time Frame - Baseline):
The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants with RET-Positive Specimens as Called by the Central Lab, which is also RET-Positive as Called by a Local Lab (Positive Percent Agreement)

18. Time to CNS Progression per RECIST 1.1 by BICR (with Pembrolizumab) (Time Frame - Baseline through CNS Progression or Death (Estimated at up to 24 Months)):
Time to CNS Progression per RECIST 1.1 by BICR (with Pembrolizumab)

19. Time to CNS Progression per RECIST 1.1 by BICR (with or without Pembrolizumab) (Time Frame - Baseline through CNS Progression or Death (Estimated at up to 24 Months)):
Time to CNS Progression per RECIST 1.1 by BICR (with or without Pembrolizumab)

20. Intracranial ORR: Percentage of Participants with Intracranial CR or PR per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) by BICR (with Pembrolizumab) (Time Frame - Baseline through CNS Progression or Death (Estimated at up to 24 Months)):
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with Pembrolizumab)

21. Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with or without Pembrolizumab) (Time Frame - Baseline through CNS Progression or Death (Estimated at up to 24 Months)):
Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with or without Pembrolizumab)

22. Intracranial DOR per RANO-BM by BICR (with Pembrolizumab) (Time Frame - Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause (Estimated at up to 24 Months)):
Intracranial DOR per RANO-BM by BICR (with Pembrolizumab)

23. Intracranial DOR per RANO-BM by BICR (with or without Pembrolizumab) (Time Frame - Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause (Estimated at up to 24 Months)):
Intracranial DOR per RANO-BM by BICR (with or without Pembrolizumab)

Studien-Arme

  • Experimental: Selpercatinib
    Selpercatinib administered orally.
  • Active Comparator: Pemetrexed with or without Pembrolizumab
    Pemetrexed administered intravenously (IV) plus the investigator's discretion of carboplatin IV or cisplatin IV with or without pembrolizumab IV.
  • Active Comparator: Pemetrexed with Pembrolizumab
    Pemetrexed administered IV plus the investigator's discretion of carboplatin IV or cisplatin IV with pembrolizumab IV.

Geprüfte Regime

  • Selpercatinib (LY3527723 / LOXO-292 / ):
    Administered orally
  • Carboplatin:
    Administered IV
  • Cisplatin:
    Administered IV
  • Pemetrexed:
    Administered IV
  • Pembrolizumab:
    Administered IV

Quelle: ClinicalTrials.gov


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