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New treatment option for Locally Advanced, Metastatic, or Recurrent Non-small Cell Lung Cancer...
Official title JS212 Plus JS111 in EGFR-Mutant Advanced NSCLC: A Phase II Study
ClinicalTrials.gov ID: NCT07518160
What this study is testing
What is JS212 for Injection＋JS111 capsules (AP-L1898)?
JS212 for Injection＋JS111 capsules (AP-L1898) is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for locally advanced, metastatic, or recurrent non-small cell lung cancer (nsclc) harboring epidermal growth factor receptor (egfr) mutations.
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
- This is a Phase II study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of JS212 in combination with JS111 in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR-sensitizing mutations who have progressed after prior EGFR-TKI therapy. The study consists of two parts: a dose-escalation phase followed by an expansion phase.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Participants must meet all of the following criteria to be eligible for this study:
- Age between 18 and 75 years (inclusive) at the time of signing the informed consent form (ICF), regardless of sex;
- Histologically or cytologically confirmed recurrent or metastatic non-squamous NSCLC that is unresectable and not amenable to curative...
- Confirmed EGFR-sensitizing mutation, including: Exon 19 deletion or L858R mutation,Either alone or in combination with other EGFR mutations...
- Prior treatment with: EGFR-TKIs, and If applicable, ≤1 line of platinum-based doublet chemotherapy, with radiologically confirmed disease progression...
You likely can't join if
- Participants meeting any of the following criteria will be excluded from the study:
- Disease-related conditions: a. Histologically or cytologically confirmed presence of: Small cell lung cancer component, or Large cell neuroendocrine...
- Prior/concomitant treatments:
- Within: 4 weeks or 5 half-lives (whichever is shorter) prior to first dose: chemotherapy or similar therapies;7 days: small molecule targeted...
- Use of strong CYP3A inhibitors or inducers within 14 days prior to first dose or requirement for continued use during study;
- Current use or requirement for use of medications known to prolong QT interval or cause torsades de pointes;
See the full eligibility criteria
Who can join
- Participants must meet all of the following criteria to be eligible for this study:
- Age between 18 and 75 years (inclusive) at the time of signing the informed consent form (ICF), regardless of sex;
- Histologically or cytologically confirmed recurrent or metastatic non-squamous NSCLC that is unresectable and not amenable to curative chemoradiotherapy;
- Confirmed EGFR-sensitizing mutation, including: Exon 19 deletion or L858R mutation,Either alone or in combination with other EGFR mutations, Including those with concurrent T790M mutation positivity.Local laboratory...
- Prior treatment with: EGFR-TKIs, and If applicable, ≤1 line of platinum-based doublet chemotherapy, with radiologically confirmed disease progression per RECIST v1.1;
- At least one measurable lesion per RECIST v1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Estimated life expectancy of ≥12 weeks;
- Adequate organ function meeting the following criteria (Note: No blood transfusion or hematopoietic growth factors are allowed within 14 days prior to screening assessments):
- Absolute neutrophil count ≥1.5 × 10⁹/L;
- Platelet count ≥100 × 10⁹/L;
- Hemoglobin ≥90 g/L (≥9 g/dL);
- ALT and AST ≤2.5 × ULN (≤5 × ULN in case of liver metastases);
- Total bilirubin ≤1.5 × ULN;
- Creatinine clearance ≥50 mL/min (calculated by Cockcroft-Gault formula);
- Activated partial thromboplastin time (APTT) ≤1.5 × ULN and international normalized ratio (INR) ≤1.5(patients on stable anticoagulant therapy such as low molecular weight heparin or warfarin are allowed if INR is...
- Female participants of childbearing potential (WOCBP) who are sexually active with non-sterilized male partners must: Have a negative serum pregnancy test within 7 days prior to first dose, and Agree to highly effective...
- Non-sterilized male participants who are sexually active with women of childbearing potential must: Agree to use effective contraception as described in Section 10.3.2 from signing the ICF until 4 months after the last...
- Participants must voluntarily participate in this study and provide written informed consent.
What rules you out
- Participants meeting any of the following criteria will be excluded from the study:
- Disease-related conditions: a. Histologically or cytologically confirmed presence of: Small cell lung cancer component, or Large cell neuroendocrine carcinoma, or Sarcomatoid features, or Squamous component \>10%; b...
- Prior/concomitant treatments:
- Within: 4 weeks or 5 half-lives (whichever is shorter) prior to first dose: chemotherapy or similar therapies;7 days: small molecule targeted therapy; 2 weeks: localized radiotherapy (e.g., palliative radiation for bone...
- Use of strong CYP3A inhibitors or inducers within 14 days prior to first dose or requirement for continued use during study;
- Current use or requirement for use of medications known to prolong QT interval or cause torsades de pointes;
- Receipt of any investigational drug within 4 weeks or 5 half-lives prior to first dose (whichever is shorter);
- Participation in another clinical trial, unless it is: Observational (non-treatment), or The participant is in the follow-up phase of an treatment study;
- Major surgery (e.g., craniotomy, thoracotomy, laparotomy) within 4 weeks prior to first dose;
- Toxicity Unresolved toxicities from prior anti-tumor therapy that have not recovered to: ≤ CTCAE Grade 1, or The level specified in inclusion/exclusion criteria,whichever is more severe (Grade 2 toxicities deemed not...
- Hypersensitivity Known allergy or hypersensitivity to any study drug or its excipients;
- Cardiac conditions:
- QTcF:≥450 ms (male), ≥470 ms (female), averaged from 3 ECG measurements;
- Clinically significant arrhythmias, including but not limited to:Complete left bundle branch block,Third-degree AV block,Second-degree AV block,PR interval \>250 ms;
- Risk factors for torsades de pointes, such as: Clinically significant hypokalemia,Family history of long QT syndrome or arrhythmias;
- Left ventricular ejection fraction (LVEF) \<50%;
- Gastrointestinal conditions Conditions affecting drug absorption, distribution, metabolism, or excretion, such as: Inability to swallow oral medication, Persistent vomiting,Uncontrolled diarrhea,Extensive...
- Pulmonary conditions History of or suspected: Interstitial lung disease, Drug-induced pneumonitis,Idiopathic pneumonitis,Idiopathic pulmonary fibrosis,or other significant pulmonary disease (≤Grade 1 radiation...
- Ocular conditions Severe or uncontrolled ocular disorders that may increase risk, including: Severe dry eye syndrome,Keratoconjunctivitis sicca,Severe exposure keratitis, or other conditions predisposing to epithelial...
- Infection Severe infection (CTCAE ≥ Grade 3) within 4 weeks prior to first dose; Evidence of active pulmonary inflammation on imaging at baseline; Infection requiring systemic antibiotics within 2 weeks prior to first...
- Immunodeficiency History of immunodeficiency, including HIV positivity;Other acquired or congenital immunodeficiency;History of organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic...
- Tuberculosis Active tuberculosis, or History of active tuberculosis within 1 year prior to enrollment, or History of active tuberculosis \>1 year ago without adequate treatment;
- Viral hepatitis Active HBV infection: HBsAg positive with HBV DNA ≥1000 copies/mL or ≥200 IU/mL; Active HCV infection: HCV antibody positive with detectable HCV RNA above LLOQ;
- Other malignancies Any other malignancy requiring treatment within 5 years prior to first dose, except: Malignancies with low metastatic risk and \>90% 5-year survival, such as: Adequately treated basal or squamous cell...
- Pregnancy and lactation Pregnant or breastfeeding women, or those planning pregnancy during the study;
- Uncontrolled comorbidities Including but not limited to: Symptomatic congestive heart failure within 6 months, Uncontrolled hypertension, Unstable angina, Uncontrolled arrhythmia, Major seizure disorders,Superior vena...
- Investigator judgment Any condition that, in the investigator's opinion, may: Lead to premature discontinuation,Compromise patient safety, or Affect data integrity, including abnormal laboratory values or unfavorable...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. 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.