An Open Label, Multicenter Phase II Clinical Study on the Safety, Tolerability, and Efficacy of FH-006 Injection Combined With Other Anti-tumor Therapies in Lung Cancer Subjects

Plain English Summary

A Phase II Clinical Study of FH-006 for Injection Combined With Other Anticancer Therapies in Subjects With Lung Cancer is a Phase 2 clinical trial sponsored by Jiangsu HengRui Medicine Co., Ltd. studying Lung Cancer. This trial is testing a new drug called FH-006 when given with other cancer treatments for lung cancer. It is for adults aged 18-75 with advanced or spreading non-small cell lung cancer that cannot be treated with surgery or radiation. Participation involves receiving FH-006 along with other anti-cancer therapies, and regular check-ups to monitor safety and effectiveness. Alternative treatments may include standard chemotherapy, targeted therapy, or immunotherapy, depending on the specific type and stage of lung cancer. The trial aims to enroll 200 participants.

Official Summary

Evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in combination with other anti-tumor treatments in lung cancer subjects, and determine the recommended dose (RP2D) and initial efficacy for phase II clinical trials.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 to 75 with non-small cell lung cancer that has spread or is advanced and not suitable for surgery or radiation. Patients must have at least one measurable tumor, good organ function, and a general health status (ECOG score 0 or 1). Individuals with active brain tumors, recent major bleeding, serious heart or lung conditions, or other active cancers may not be eligible. Women who are pregnant or planning to become pregnant within 14 months after the study also cannot participate. This trial is studying Lung Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes will show how safe and well-tolerated the new treatment is, and whether it helps shrink tumors or control the cancer's growth, guiding doctors on the best dose for future studies. The specific primary outcome measures are: DLT (Dose-limiting toxicity)：Severe toxicity occurred 21 or 28 days after each subject received their first systemic anticancer treatment. (21or28 days after the first administration of each subject); Incidence of Treatment-Emergent Adverse Events (from first dose to disease progression or death, up to 3 years.); RP2D (Recommended Phase II Dose)：This was determined through a comprehensive evaluation of safety data and pharmacokinetic characteristics. (from first dose to disease progression or death, up to 3 years); ORR (Objective Response Rate) (from first dose to disease progression or death, whichever comes first, up to 3 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial aims to find a better treatment combination for lung cancer by evaluating FH-006, potentially filling a gap for patients with advanced disease who have limited options. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Lung Cancer, where improved treatment options are needed.

Investor Insight

This trial signals potential for a new combination therapy in the large lung cancer market, with Jiangsu HengRui Medicine Co., Ltd. as the sponsor, suggesting a competitive landscape and a moderate pr Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific combination therapies being used and what to expect regarding side effects. Understand the schedule of visits, tests, and treatments involved in the trial. Be prepared for regular monitoring of your health and cancer progression throughout the study. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 200 participants

Interventions

• DRUG: FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin — FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin
• DRUG: FH-006 ; SHR-1316 ; BP102 — FH-006 ; SHR-1316 ; BP102
• DRUG: FH-006; SHR-1316 ; SHR-8068 — FH-006; SHR-1316 ; SHR-8068

Primary Outcomes

• DLT (Dose-limiting toxicity)：Severe toxicity occurred 21 or 28 days after each subject received their first systemic anticancer treatment. (21or28 days after the first administration of each subject)
• Incidence of Treatment-Emergent Adverse Events (from first dose to disease progression or death, up to 3 years.)
• RP2D (Recommended Phase II Dose)：This was determined through a comprehensive evaluation of safety data and pharmacokinetic characteristics. (from first dose to disease progression or death, up to 3 years)
• ORR (Objective Response Rate) (from first dose to disease progression or death, whichever comes first, up to 3 years)

Secondary Outcomes

• Duration of response (DoR) (from first dose to disease progression or death, whichever comes first, up to 3 years)
• disease control rate (DCR) (from first dose to disease progression or death, whichever comes first, up to 3 years)
• progression free survival (PFS) (from first dose to disease progression or death, whichever comes first, up to 3 years)
• overall survival (OS) (from first dose to disease progression or death, whichever comes first, up to 3 years)

Full Eligibility Criteria

Inclusion Criteria:

1. Age range: 18-75 years old (including both ends), gender is not limited.
2. Subjects with locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology as unsuitable for radical surgery or radiotherapy treatment
3. ECOG score is 0 or 1
4. Expected survival period ≥ 12 weeks
5. According to the RECIST v1.1 standard, there must be at least one measurable lesion.
6. Good level of organ function
7. The patient voluntarily joined this study and signed informed consent
8. Left ventricular ejection fraction (LVEF) ≥ 50%

Exclusion Criteria:

1. Suffering from other malignant tumors within the past 5 years
2. Subjects with active central nervous system (CNS) tumor metastasis, a history of meningeal metastasis, or current meningeal metastasis
3. Patients with uncontrollable tumor related pain
4. Has serious cardiovascular and cerebrovascular diseases
5. Significant clinically significant bleeding symptoms occurred within 3 months prior to the first study medication
6. Uncontrollable third interstitial fluid accumulation within 2 weeks of initial study medication
7. History of clinically significant pulmonary diseases
8. Receive other anti-tumor treatments within 4 weeks before the first medication
9. Severe infection within 4 weeks before the first medication
10. Active, known or suspected autoimmune diseases, and a history of autoimmune diseases.
11. History of immunodeficiency
12. Individuals with active pulmonary tuberculosis infection within the year prior to enrollment
13. Chest radiation therapy patients who received\>30 Gy within 24 weeks prior to the first use of the investigational drug
14. The adverse reactions of previous anti-tumor treatments have not yet recovered to ≤ Grade I
15. Surgical treatment of important organs within 4 weeks prior to the first use of medication
16. Use attenuated live vaccine within 28 days prior to the first use of the investigational drug
17. There are other serious physical or mental illnesses or laboratory abnormalities present
18. Pregnant, lactating women, or female participants who plan to become pregnant within 14 months after the last use of the investigational drug during the study period
19. Having bleeding tendency, high risk of bleeding, coagulation dysfunction or thrombophilia tendency
20. Previously experienced hypertensive crisis or hypertensive encephalopathy
21. Suffering from significant vascular disease within 6 months prior to the first use of medication
22. Have undergone a biopsy or other minor surgery within 7 days prior to the first use of medication
23. Having severe, unhealed wounds, active ulcers, or untreated fractures
24. Gastrointestinal perforation occurred within 6 months prior to the first use of medication
25. 24-hour proteinuria quantification ≥ 1g within 7 days before the first medication
26. CT/MRI indicates tumor surrounding or invading large blood vessels

Trial Locations

• Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Frequently Asked Questions

Related Conditions

• Lung Cancer
• Non-Small Cell Lung Cancer
• Metastatic Lung Cancer
• Advanced Lung Cancer
• Oncology
• Cancer Therapy
• Immunotherapy
• Chemotherapy
• Targeted Therapy
• Thoracic Oncology

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