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Additional Chemotherapy for EGFRm Patients with the Continued Presence of Plasma CtDNA EGFRm At Week 3 After Start of Osimertinib 1st-line Treatment (PACE-LUNG)

ConditionsNSCLC Stage IIIBNSCLC Stage IV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGoethe University

About this trial

PACE is a prospective multicenter single-arm investigator-initiated phase II trial that examines the value of a treatment escalation strategy by the addition of platinum-based doublet chemotherapy to osimertinib in patients with treatment-naïve NSCLC harboring L858R or del19 EGFR mutation who are suspected to have poor response upon single-agent TKI treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of written informed consent for the pre-screening phase.

Age ≥ 18 years

Histologically confirmed stage IIIB or IV NSCLC

Tumor positive for Ex19del or L858R EGFR mutation assessed according to local standard.

Disqualifiers

Malignancy treated with curative intent and with no known active disease ≥6 months before the first dose of IMP, and of low potential risk for recurrence

Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease

Adequately treated carcinoma in situ without evidence of disease

History of leptomeningeal carcinomatosis

Trial design

Design model

Single group

Treatments tested in this trial

  • Osimertinib

    Drug

    80 mg daily or reduced dose 40 mg daily

  • Pemetrexed

    Drug

    500 mg/m² i.v. d1 of every 21-day cycle for a maximum of 4 cycles

  • Cisplatin

    Drug

    75mg/m² i.v. d1 of every 21-day cycle for a maximum of 4 cycles

  • Carboplatin

    Drug

    AUC 5 mg/mL/min i.v. d1 of every 21-day cycle for a maximum of 4 cycles

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Osimertinib in combination with platinum-based chemotherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS1)

Progression Free Survival using investigator assessments according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1) defined as number of months from first dose of chemotherapy until last follow-up, PD, death or withdrawal of consent.

Time frame
2 years

Secondary outcomes

1

Progression Free Survival (PFS0)

Progression Free Survival using investigator assessments according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1) defined as number of months from first dose of osimertinib until last follow-up, PD, death or withdrawal of consent.

Time frame
for a minimum of 24 months from inclusion
2

Overall Survival (OS1)

OS1 Survival will be calculated from the first dose of chemotherapy until the date of death from any cause. If no event is observed (e.g. lost to follow-up) OS is censored at the day of last subject contact.

Time frame
for a minimum of 24 months from inclusion
3

Overall Survival (OS0)

OS0 Survival will be calculated from the date of start of osimertinib until the date of death from any cause. If no event is observed (e.g. lost to follow-up) OS is censored at the day of last subject contact.

Time frame
for a minimum of 24 months from inclusion
4

Incidence of treatment related Adverse Events (Safety and Tolerability)

Frequency and severity of Adverse Events, grading according to CTCAE V5.0

Time frame
up to 16 weeks from start of study treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Goethe University

Lead sponsor

Source ClinicalTrials.gov
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