BridgeMD
New treatment option for NSCLC Stage IIIB
Official title 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)
ClinicalTrials.gov ID: NCT05281406
What this study is testing
What is Osimertinib?
Osimertinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for nsclc stage iiib.
Also referred to as Tagrisso.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pre-Screening Phase
- 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.
You likely can't join if
- Pre-Screening Phase
- History of another primary malignancy. Exceptions are:
- 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...
- 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
See the full eligibility criteria
Who can join
- Pre-Screening Phase
- 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.
- Planned treatment with osimertinib 80mg/d 1st-line as SoC or ongoing treatment for a maximum of 28 days
- Available radiographic chest and abdominal CT or MRI scans performed up to 42 days before initial osimertinib treatment
- Previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease, except for osimertinib for a maximum of 28 days (see above)
- At least one measurable site of disease as defined by RECISTv1.1 criteria
- Female people of childbearing potential (WOCBP) should be using highly effective contraceptive measures and must have a negative urine or serum pregnancy test within 7 days prior to start of study treatment and must not...
- Non-child-bearing potential must be evidenced by fulfilling one of the following criteria at screening:
- Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
- Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal...
- Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation Treatment Phase
- Provision of informed consent for the screening and treatment phase prior to any study specific procedures, including screening evaluations that are not SoC.
- Persistent mEGFR ctDNA signal 21 to 28 days after osimertinib initiation for advanced of metastatic ex19del or L858R EGFR mutation positive NSCLC as assessed by a liquid biopsy during the pre-screening phase of the...
- ECOG performance status 0-2.
- The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.
- Osimertinib no longer than 10 weeks before start of chemotherapy in the treatment phase
What rules you out
- Pre-Screening Phase
- History of another primary malignancy. Exceptions are:
- 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
- Concurrent enrolment in another clinical study, unless it is an observational (non-treatment) clinical study, or during the follow-up period of an treatment study
- Previous enrolment in the present study. Treatment Phase
- Symptomatic CNS metastases. [Patients with asymptomatic brain metastases may be included.]
- History of leptomeningeal carcinomatosis
- Currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 weeks prior) (Appendix 20.5). All...
- Osimertinib had to be withheld or administered at reduced dosage for toxicity management for more than 7 days or persistent unresolved toxicities which preclude study treatment.
- Any unresolved toxicities other than osimertinib from prior therapy greater than CTCAE grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2 prior platinum-therapy-related...
- History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib. History of hypersensitivity to any of the chemotherapy drugs used.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the...
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib.
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) \> 470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block.
- Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: Serum/plasma potassium \< LLN; Serum/plasma magnesium \< LLN...
- Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
- Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
- Absolute neutrophil count below lower limit of normal (\<LLN) \
- Platelet count below lower limit of normal (\<LLN) \
- Hemoglobin \<90 g/L \ \ The use of granulocyte colony stimulating factor support, platelet transfusion and blood transfusions to meet these criteria is not permitted.
- Alanine aminotransferase \>2.5 times ULN if no demonstrable liver metastases or \>5 times ULN in the presence of liver metastases;
- Aspartate aminotransferase \>2.5 times ULN if no demonstrable liver metastases or \>5 times ULN in the presence of liver metastases;
- Total bilirubin \>1.5 times ULN if no liver metastases or \>3 times ULN in the presence of documented Gilbert's Syndrome [unconjugated hyperbilirubinaemia] or liver metastases;
- Serum creatinine \>1.5 times ULN concurrent with creatinine clearance \ 1.5 times ULN.
- INR ≤ 1.4 or aPTT ≤ 40 sec during the last 7 days before chemotherapy [people under therapeutic anticoagulation are permitted.]
- Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
- Women who are pregnant or breast-feeding
- Male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 4 months (male patients) or 6 weeks (female patients) after the last dose of osimertinib and 6...
- Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S...
- Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater.
- Any chemotherapy, biologic, or hormonal therapy for cancer treatment used concurrently or within 6 months prior to first dose of study treatment. Concurrent use of hormonal therapy for non-cancer-related conditions...
- Major surgery (as defined by the Investigator) within 4 weeks prior to starting the study; patients must have recovered from effects of preceding major surgery. Note: Local non-major surgery for palliative intent (e.g...
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
- Cologne, Germany
- Dresden, Germany
- Essen, Germany
- Frankfurt, Germany
- Gauting, Germany
- Georgsmarienhütte, Germany
- Göttingen, Germany
- Halle, Germany
- Hamburg, Germany
- Heidelberg, Germany
- Hemer, Germany
- Mainz, Germany
- München, Germany
- Nuremberg, Germany
- Oldenburg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany; Cologne, Germany; Dresden, Germany; Essen, Germany; Frankfurt, Germany; Gauting, Germany and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.