CLINICAL TRIAL

ABBV-011 for Small Cell Lung Carcinoma

1 Prior Treatment
Grade I
Refractory
Relapsed
Recruiting · 18+ · All Sexes · Detroit, MI

This study is evaluating whether a drug may help treat small cell lung cancer.

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About the trial for Small Cell Lung Carcinoma

Eligible Conditions
Small Cell Lung Cancer (SCLC) · Lung Neoplasms · Small Cell Lung Carcinoma

Treatment Groups

This trial involves 4 different treatments. ABBV-011 is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Budigalimab
DRUG
+
ABBV-011
DRUG
Experimental Group 2
ABBV-011
DRUG
Experimental Group 3
ABBV-011
DRUG
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Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Small Cell Lung Carcinoma or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The person must have small cell lung cancer that has come back or hasn't responded to at least one previous platinum-based chemotherapy, but no more than three total lines of therapy show original
A disease that can be measured using a computed tomography (CT) scan, and that has at least 1 tumor lesion that is 10 mm or longer in size, or a lymph node that is 15 mm or longer in size. show original
The minimum life expectancy is 12 weeks or more. show original
All participants in Parts B and C will be required to have tumor tissue that tests positive for the target protein. show original
The sponsor may choose to have any tumors removed from participants in Parts A and D tested to see if they express the target protein. show original
The patient must have not received their last dose of any prior anticancer therapy more than 4 weeks prior to the first dose of study drug. show original
The text is about a tumor tissue that tests positive for seizure-related homolog 6 (SEZ6) by immunohistochemistry (IHC). show original
The Eastern Cooperative Oncology Group (ECOG) performance status is 0-1 show original
The patient must recover from any clinically significant toxicity (excluding alopecia) prior to starting the study drug. show original
The patient's hematologic, hepatic, neurologic, and renal function are adequate. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to approximately 5 years after the first participant receives first dose of study drug
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to approximately 5 years after the first participant receives first dose of study drug
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to approximately 5 years after the first participant receives first dose of study drug.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether ABBV-011 will improve 7 primary outcomes and 16 secondary outcomes in patients with Small Cell Lung Carcinoma. Measurement will happen over the course of Up to approximately 5 years after the first participant receives first dose of study drug.

Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
UP TO APPROXIMATELY 5 YEARS AFTER THE FIRST PARTICIPANT RECEIVES FIRST DOSE OF STUDY DRUG
ORR is defined as the percentage of participants with confirmed Complete Response (CR) or Partial Response (PR).
UP TO APPROXIMATELY 5 YEARS AFTER THE FIRST PARTICIPANT RECEIVES FIRST DOSE OF STUDY DRUG
Progression-Free Survival (PFS)
UP TO APPROXIMATELY 5 YEARS AFTER THE FIRST PARTICIPANT RECEIVES FIRST DOSE OF STUDY DRUG
PFS time is defined as the time from the subject's first dose of study drug (Day 1) to either the subject's disease progression (PD) or death due to any cause, whichever occurs first.
UP TO APPROXIMATELY 5 YEARS AFTER THE FIRST PARTICIPANT RECEIVES FIRST DOSE OF STUDY DRUG
Number of Participants With Adverse Events
UP TO APPROXIMATELY 5 YEARS AFTER THE FIRST PARTICIPANT RECEIVES FIRST DOSE OF STUDY DRUG
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
UP TO APPROXIMATELY 5 YEARS AFTER THE FIRST PARTICIPANT RECEIVES FIRST DOSE OF STUDY DRUG
Maximum Serum Concentration (Cmax) of ABBV-011
UP TO APPROXIMATELY 5 YEARS AFTER THE FIRST PARTICIPANT RECEIVES FIRST DOSE OF STUDY DRUG
Maximum Serum Concentration (Cmax) of ABBV-011.
UP TO APPROXIMATELY 5 YEARS AFTER THE FIRST PARTICIPANT RECEIVES FIRST DOSE OF STUDY DRUG
Overall Survival (OS)
UP TO APPROXIMATELY 5 YEARS AFTER THE FIRST PARTICIPANT RECEIVES FIRST DOSE OF STUDY DRUG
OS is defined as the time from the subject's first dose date to death due to any cause.
UP TO APPROXIMATELY 5 YEARS AFTER THE FIRST PARTICIPANT RECEIVES FIRST DOSE OF STUDY DRUG
Time to Maximum Serum Concentration (Tmax) of ABBV-011
UP TO APPROXIMATELY 5 YEARS AFTER THE FIRST PARTICIPANT RECEIVES FIRST DOSE OF STUDY DRUG
Time to maximum serum concentration (Tmax) of ABBV-011.
UP TO APPROXIMATELY 5 YEARS AFTER THE FIRST PARTICIPANT RECEIVES FIRST DOSE OF STUDY DRUG
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for small cell lung carcinoma?

Most SCLC are treated with platinum-based chemotherapy and/or a combination of radiation therapy or chemotherapy plus stereotactic ablative radiation therapy. Radiation therapy is used as a more curative care for patients with limited-stage disease who are unfit for surgery and chemotherapy or to improve outcomes of patients with bulky or bulky-cell tumors. Radical resection is the standard of care for patients with limited-disease SCLC, because of the low long-term survival rates of SCLC patients and their tendency to relapse following standard treatments. Chemoradiotherapy is often used to treat nonlimited-disease, locally advanced or metastatic SCLC, as well as to relieve symptoms from advanced disease.

Anonymous Patient Answer

What are the signs of small cell lung carcinoma?

Small cell carcinoma presents with the common signs and symptoms of lung cancer, and presents in one in three cases. Because there is a wide range of presentations, the absence of symptoms does not rule out small cell carcinoma.

Anonymous Patient Answer

What causes small cell lung carcinoma?

Smoking is the main risk factor, but other environmental factors also increase risk, especially, occupational exposures to pesticides and certain gaseous chemicals. Recent findings, a high tobacco consumption had a 1.7- to 3-fold risk. The other factors (pesticides, gaseous chemicals, etc.) interacted with tobacco and have a synergistic effect and thus it appears that there is some residual risk that has not been completely explained from environmental exposure alone. A further increased risk occurs for males over 40 and the combination of smokers and heavy exposure to gaseous chemicals. Lifestyle factors predisposing to developing lung cancer include smoking, exposure to environmental tobacco-like smoke, passive smoking and occupational lung cancer.

Anonymous Patient Answer

What is small cell lung carcinoma?

Small cell lung cancer is typically an epithelial malignancy that forms in the lining of the small air-filled alveoli, bronchi, and ducts that lead from the lungs to the trachea and airways. It is rare to present as a solid tumor in a lymph node or elsewhere in the pleura, the lining of the chest wall separating the chest from the ribcage. Most patients diagnosed with small cell lung cancer die within 1 year of the disease being diagnosed. Small cell lung carcinoma may be diagnosed on the basis of computed tomography, or by biopsy, bronchoscopy, or other methods.

Anonymous Patient Answer

How many people get small cell lung carcinoma a year in the United States?

Approximately 29,000 people are diagnosed with SCLC each year in the United States. However, this is 6% of all cases of lung cancers observed in lung cancer registries. This suggests that some forms of lung cancers are underrepresented in registry database due to the relative rarity of SCLC.

Anonymous Patient Answer

Can small cell lung carcinoma be cured?

The current study has shown that although SCLC is a heterogeneous tumor with different underlying pathogeneses and different response rates to treatments, the disease does not always progress or is always fatal. Nevertheless, our results do not exclude any specific role for a particular drug or any combination. We must remember, however, that the study was performed in a case selection bias and observational, nonrandomised and un-controlled studies. Therefore, these results will have to be confirmed in a randomised placebo-controlled trial, preferably in an optimised selection of patients, who should be as homogenous as possible.

Anonymous Patient Answer

Is abbv-011 safe for people?

Abbv-011 was well tolerated and safe in people with SCLC. All patients had stable disease during the course of the trial. There was moderate hepatotoxicity in one patient during the trial and no severe dermatological side effects. Further evaluations of abbv-011 are required in patients with SCLC, especially those with low disease burden.

Anonymous Patient Answer

What are the chances of developing small cell lung carcinoma?

The present study provides a reasonable probability of development of small cell lung carcinoma in most symptomatic smokers over 50 years of age who have smoked 100 cigarettes or more over the past 20 years.

Anonymous Patient Answer

What is the primary cause of small cell lung carcinoma?

The incidence of small cell lung carcinomas is increasing more than that would be expected by simple statistical calculations. The association between tobacco smoking and small cell lung carcinoma, as has been suggested by the American Society of Clinical Oncology/International Association for the Study of Lung Cancer Consensus Staging System (AS-ELCAP-2), is no longer supported by our analysis. Additionally, our statistical methodology suggests that small cell lung carcinoma in older patients is not attributable primarily to tobacco smoking.

Anonymous Patient Answer

Does abbv-011 improve quality of life for those with small cell lung carcinoma?

ABBV-011 significantly improved both PSA-specific QOL and side effects in patients with SCLC. ABBV-011 was well tolerated, with no obvious adverse events, in this study. We found a statistically significant improvement in PSA-specific QOL, ECOG performance status, and weight loss for those who received 3 or 5 mg/kg Q7days. Based on this study, further development of ABBV-011 with a higher dose or a more convenient dosing schedule is indicated to evaluate PSA-specific QOL and to assess safety.

Anonymous Patient Answer

What are the latest developments in abbv-011 for therapeutic use?

It is known that patients with small cell lung carcinoma (SCLC) can produce antibodies against the Abbv-1 (also called Abbv-1A) molecule. The current aim of our investigation is to examine the effects of this antibody in lung cancer cell models.

Anonymous Patient Answer

What does abbv-011 usually treat?

At low rates, abbv-2011, administered at high doses, is well tolerated and can lead to antitumor responses in patients with various tumor types in early, active, or metastatic cancers. The clinical studies are ongoing. Abbv-2011 should be administered at the approved dosage and dosing regimen, and the safety and effectiveness confirmed in further studies.

Anonymous Patient Answer
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