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Small Cell Carcinoma of LungPhase 1/2NCT07414927

A Clinical Study for the Efficacy and Safety of BL0020 Injection in Patients With Small Cell Lung Cancer Transformed From Non-Small Cell Lung Cancer Following EGFR TKI Therapy

A Phase 1/2 study testing BL0020 in people with Small Cell Carcinoma of Lung, run by Shanghai Best-Link Bioscience, LLC at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The primary treatment option for non-small cell lung cancer (NSCLC) adenocarcinoma with activating epidermal growth factor receptor (EGFR) mutation is EGFR tyrosine kinase inhibitor (TKI). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Carcinoma of Lung
What is being tested?
BL0020
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
27 Mar 2026to 20 Feb 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Volunteer to participate in the study, be able to understand the requirements of a clinical study, and willingness to sign a written informed consent form.
  • Aged ≥ 18 years, male or female.
  • Patients with initial diagnosis of EGFR-mutated NSCLC and histologically or cytologically confirmed transformation to SCLC following treatment with EGFR tyrosine kinase inhibitor.
  • After transformation to SCLC, the patient's prior treatment history must meet one of the following criteria:
  • Progression after only receiving platinum-based treatment regimens.
  • No prior systemic therapy for SCLC.
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening.
  • Life expectancy ≥ 12 weeks.

Who cannot join

  • Patients with symptomatic brain metastases or carcinoma meningitis. Note:
  • Patients with treated brain metastases may participate in this study if the patient has completed radiotherapy or surgery for brain metastases ≥ 4 weeks prior to study entry, and neurologically stable ≥ 4 weeks after radiotherapy or surgery treatment [i.e., no new findings on brain imaging and no new neurologic deficits from brain metastasis on screening examination, and high doses of corticosteroids (> 10 mg prednisone daily or equivalent) were not required within 4 weeks prior to enrollment].
  • Patients with brainstem metastases or spinal cord compression (detected by radiographic imaging, even if they did not have symptoms) were not eligible.
  • Patients who have a history of another primary malignancy (with the exception of patients with cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of uterine cervix). A patient who has had no evidence of disease from another primary cancer for 3 or more years is allowed to participate in the study.
  • Patients with tumors that had invaded important blood vessels as shown in the screening imaging and that the investigators assessed were highly likely to cause fatal bleeding during the study.
  • Patients whose pericardial effusion, pleural effusion or ascites remain uncontrollable after intervention.
Show all 15Show fewer
  • Patients with Gilbert's syndrome disease.
  • Patients who have a known diagnosis of Human Immunodeficiency Virus (HIV) infection or HIV antibody test positive during screening.
  • Patients with active hepatitis C or chronic hepatitis B at screening ("active hepatitis" defined as HCV RNA level ≥ 200 IU/mL for hepatitis C or HBV DNA level ≥ 2000 IU/mL for hepatitis B at screening). In addition, eligible hepatitis B or hepatitis C patients must agree to antiviral treatment according to the treatment guidelines.
  • Patients who have not sufficient baseline organ function.
  • Those who are known to be allergic to the active ingredient or excipients of the investigational product BL0020 Injection, or who have a predisposition to allergy.
  • Patients who are taking anticoagulant therapy (prophylactic use of low-dose aspirin [≤ 100 mg/day] or low molecular weight heparin is allowed).
  • Those who have received live or attenuated vaccines (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, BCG, typhoid vaccine, etc.) within 4 weeks before enrollment or scheduled to receive during the study.
  • Pregnant or lactating women.
  • Patients who are assessed disqualified to join clinical studies by investigator due to any causes.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhuolun Fang contact

+86 18357916536

fangzhuolun@bestlinkbio.com

China1 site

  • Shanghai Chest Hospital

    Shanghai, 200030

    Shun Lu

    Shun Lu

Other trials in China

About this study

Official title: An Open-Label, Single-Arm Phase I/II Clinical Study to Evaluate the Efficacy and Safety of BL0020 Injection in Patients With Small Cell Lung Cancer Transformed From Non-Small Cell Lung Cancer Following EGFR TKI Therapy

The primary treatment option for non-small cell lung cancer (NSCLC) adenocarcinoma with activating epidermal growth factor receptor (EGFR) mutation is EGFR tyrosine kinase inhibitor (TKI). After a certain period of treatment with EGFR TKI, acquired resistance emerges most frequently with a secondary mutation, p.T790M, followed by MET amplification. Interestingly, up to 3-14% of patients experience histological transformation into small cell lung cancer (SCLC), which has an aggressive clinical course and a poor prognosis.

The transformed SCLC retains the original EGFR mutation but significantly down regulates EGFR protein expression, eliminating its dependence on EGFR signaling while simultaneously acquiring a neuroendocrine phenotype. In nearly all cases, bi-allelic inactivation of both TP53 and RB1 is observed. However, little is known about the clinical outcomes of transformed SCLC, with limited studies arguing that their outcomes are similar to those of de novo SCLC, where the median overall survival is approximately 9 to 10 months after the transformation.

Read more

At present, there is no standard treatment regimen for patients with SCLC transformed from NSCLC following EGFR TKI therapy.

BL0020 is a polymer-drug conjugate consisting of Topoisomerase I inhibitor SN-38 (7-ethyl-10-hydroxycamptothecin) conjugated by a peptide linker to a PEG-modified poly(ε-L-lysine) polymer. In the ongoing first-in-human study of BL0020, significant efficacy has been observed with BL0020 monotherapy in SCLC patients who have relapsed or progressed following at least first-line platinum-based systemic treatment.

Based on previous clinical and preclinical outcomes that show similar disease characteristics between SCLC transformed from NSCLC following EGFR TKI therapy and de novo SCLC, this study is designed to evaluate the clinical efficacy and safety of BL0020 in patients with transformed SCLC.

Being tested
BL0020
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BL0020Drug

    BL0020 will be administered via intravenous infusion on Day 1 of each 21-day treatment cycle.

Study groups in NCT07414927
Study groupRoleWhat they receive
BL0020ExperimentalNot described
Receives: Drug: BL0020

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    ORR is defined as the proportion of patients with the best responses of Complete Response (CR) and Partial Response (PR) observed after study treatment

    Measured: Throughout the study for approximately 2 years

Secondary outcomes (11)

  1. Duration of response (DOR)

    DOR is defined as the time from the initial response (complete response [CR] or partial response [PR]) until first objective radiographic tumor progression or death from any cause

    Measured: Throughout the study for approximately 2 years

  2. Disease control rate (DCR)

    DCR is the sum of complete response (CR), partial response (PR), and stable disease (SD) rates

    Measured: Throughout the study for approximately 2 years

  3. Progression-free survival (PFS)

    PFS is defined as the time from the start date of study treatment until first objective radiographic tumor progression or death from any cause

    Measured: Throughout the study for approximately 2 years

  4. Overall survival (OS)

    OS is defined as the time from the start date of study treatment until death from any cause

    Measured: Throughout the study for approximately 2 years

  5. 3-Month Progression-Free Survival (PFS3)

    PFS3 is defined the proportion of patients who have not experienced first objective radiographic tumor progression or death due to any cause after 3 months from the start date of the study treatment

    Measured: From the first study treatment to the 3-month time point

  6. 6-Month Progression-Free Survival (PFS6)

    PFS6 is defined the proportion of patients who have not experienced first objective radiographic tumor progression or death due to any cause after 6 months from the start date of the study treatment

    Measured: From the first study treatment to the 6-month time point

  7. 9-Month Progression-Free Survival (PFS9)

    PFS9 is defined the proportion of patients who have not experienced first objective radiographic tumor progression or death due to any cause after 9 months from the start date of the study treatment

    Measured: From the first study treatment to the 9-month time point

  8. 12-Month Progression-Free Survival (PFS12)

    PFS12 is defined the proportion of patients who have not experienced first objective radiographic tumor progression or death due to any cause after 12 months from the start date of the study treatment

    Measured: From the first study treatment to the 12-month time point

  9. 6-Month Overall Survival rate (OS6)

    OS6 is defined the proportion of patients who are alive 6 months from the start date of the study treatment.

    Measured: From the first study treatment to the 6-month time point

  10. 12-Month Overall Survival rate (OS12)

    OS12 is defined the proportion of patients who are alive 12 months from the start date of the study treatment

    Measured: From the first study treatment to the 12-month time point

  11. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    TEAEs are defined as those Adverse Events (AEs) with start or worsening date during the on-treatment period (from the first dose date of study treatment to 30 days after the last dose date of study treatment).

    Measured: Throughout the study for approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study start27 Mar 2026 (estimated)
  3. Primary completion22 Dec 2027 (estimated)
  4. Study completion20 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07414927
Sponsor's protocol ID
BL0020-201
Status last verified
Feb 2026
First submitted
9 Feb 2026
Last updated
17 Feb 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BL0020 in people with Small Cell Carcinoma of Lung, run by Shanghai Best-Link Bioscience, LLC at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhuolun Fang (+86 18357916536, fangzhuolun@bestlinkbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Throughout the study for approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07414927.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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