Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-small-cell-lung-cancer-hycamtin-146fc378

nct id

NCT05740566

qol key

qol-0001

source section id

NCT05740566-om-0001

source outcome index

1

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Change From Baseline in Selected Functional Scales and Disease Symptom Items Included in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

measure definition

The EORTC QLQ-C30 was developed to assess quality of life in cancer participants across tumor types. It was a self-reported, 30-item generic instrument that assessed five functional scales (physical, role, emotional, cognitive, social); nine disease symptom items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties); and a global health status (GHS)/quality of life (QOL) scale. Questionnaire score ranged from 0 to 100. For the functional scales, higher scores indicated high/healthy level of functioning; for the disease symptom scales, higher scores indicated greater symptom burden; and for the GHS/QoL scale, higher scores represented a high QoL. A negative change from baseline indicated reduction in functioning, improvement in symptom burden and reduction in health and quality of life.

time frame

Up to approximately 4 years

analysis role

secondary

reporting status

NOT_POSTED

higher is better

0

direction quote

higher scores indicated greater symptom

population note

Source null

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-small-cell-lung-cancer-hycamtin-146fc378

nct id

NCT05740566

qol key

qol-0002

source section id

NCT05740566-om-0002

source outcome index

2

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Change From Baseline in Selected Disease Symptoms Included in the European Organization for Research and Treatment of Lung Cancer Quality of Life Questionnaire (EORTC-QLQ-LC13)

measure definition

The EORTC QLQ-LC13 was a disease-specific supplement to the EORTC QLQ-C30. It included multi-item and single-item measures of lung cancer symptoms (coughing, hemoptysis, dyspnea, pain) and treatment side effects (hair loss, neuropathy, sore mouth, dysphagia). Scores ranged from 0 to 100, with higher scores indicating a greater degree of symptom severity. A negative change from baseline indicated improvement in symptom burden or side effect severity.

time frame

Up to approximately 4 years

analysis role

secondary

reporting status

NOT_POSTED

higher is better

Source null

direction quote

Source null

population note

Source null

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-small-cell-lung-cancer-hycamtin-146fc378

nct id

NCT05740566

qol key

qol-0011

source section id

NCT05740566-om-0011

source outcome index

11

instrument

Brief Pain Inventory

instrument basis

matched 'brief pain inventory' in the study's own wording

scale title

Change From Baseline in Pain Severity as Measured by Brief Pain Inventory - Short Form (BPI-SF)

measure definition

The BPI-SF (Pain) was a valid and reliable instrument, which was a commonly used tool to capture severity of pain and its impact on daily functioning. The BPI-SF measured intensity of pain at four time points (worst, least, average, and right now), pain relief, and seven interference items (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Scoring for pain ranged from 0 (no pain) to 10 (worst pain), and for pain interference from 0 (no interference) to 10 (complete interference). A negative change from baseline indicated a reduction in pain severity or interference.

time frame

Up to approximately 4 years

analysis role

secondary

reporting status

NOT_POSTED

higher is better

Source null

direction quote

Source null

population note

Source null

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-small-cell-lung-cancer-hycamtin-146fc378

nct id

NCT05740566

qol key

qol-0013

source section id

NCT05740566-om-0013

source outcome index

13

instrument

Patient-reported symptom or function measure

instrument basis

matched 'patient reported' in the study's own wording

scale title

Change From Baseline in Symptoms and Overall Status as Measured by Patient Reported Impression of Change (PGIC) Questionnaire

measure definition

PGIC measures were used in the measurement of within-patient meaningful change (response) thresholds for disease symptoms/impacts of interest. The PGIC scale asked respondents to rate the overall change in symptoms, overall status, etc., since initiating treatment with the medication. The 5-level PGIC response options were: 1: much better, 2: a little better, 3: about the same, 4: a little worse, and 5: much worse. Higher scores indicated worsening condition. A negative change from baseline indicated an improvement in symptoms.

time frame

Up to approximately 4 years

analysis role

secondary

reporting status

NOT_POSTED

higher is better

0

direction quote

Higher scores indicated worse

population note

Source null

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-small-cell-lung-cancer-hycamtin-146fc378

nct id

NCT05740566

qol key

qol-0014

source section id

NCT05740566-om-0014

source outcome index

14

instrument

EQ-5D

instrument basis

matched 'eq-5d' in the study's own wording

scale title

Summary Scores of Patient-perceived Health at Each Assessment Visit Using the Visual Analogue Scale (VAS) as Measured by the 5-Level EuroQol-5 Dimension (EQ-5D-5L)

measure definition

The EQ5D-5L questionnaire was a standardized instrument used as a measure of health outcome developed by the EuroQol group. It was comprised of a 5-dimension health status measure and a VAS. The 5-dimension health status measure evaluated: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on a 5-level scale: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: an extreme problem. Higher scores (closer to 5) indicated worse health status. The VAS recorded the participant's self-rated health on a vertical VAS where the endpoints were labelled 'Worst imaginable health state' and 'Best imaginable health state'. VAS ranged from 0 to 100. Higher scores indicated better perceived health.

time frame

Up to approximately 4 years

analysis role

secondary

reporting status

NOT_POSTED

higher is better

Source null

direction quote

Source null

population note

Source null

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-small-cell-lung-cancer-hycamtin-146fc378

nct id

NCT05740566

qol key

qol-0015

source section id

NCT05740566-om-0015

source outcome index

15

instrument

EQ-5D

instrument basis

matched 'eq5d' in the study's own wording

scale title

Change From Baseline in Patient Perceived Health Using VAS Score as Measured by EQ5D-5L

measure definition

The EQ5D-5L questionnaire was a standardized instrument used as a measure of health outcome developed by the EuroQol group. It was comprised of a 5-dimension health status measure and a VAS. The 5-dimension health status measure evaluated: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on a 5-level scale: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: an extreme problem. Higher scores (closer to 5) indicated worse health status. The VAS recorded the participant's self-rated health on a vertical VAS where the endpoints were labelled 'Worst imaginable health state' and 'Best imaginable health state'. VAS ranged from 0 to 100. Higher scores indicated better Perceived health. A negative change from baseline indicated a reduction in better perceived health.

time frame

Up to approximately 4 years

analysis role

secondary

reporting status

NOT_POSTED

higher is better

Source null

direction quote

Source null

population note

Source null

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-small-cell-lung-cancer-hycamtin-146fc378

nct id

NCT05740566

qol key

qol-0016

source section id

NCT05740566-om-0016

source outcome index

16

instrument

PRO-CTCAE

instrument basis

matched 'pro-ctcae' in the study's own wording

scale title

Responses to Patient-Reported Adverse Events Questionnaire (PRO-CTCAE)

measure definition

PRO-CTCAE was a 78-item library used to measure patient-reported symptomatic adverse events. Users selected items that were most relevant to the disease, treatment profile, and fit for purpose to document patients' experience. Each symptom was rated by up to 3 attributes: presence/frequency, severity, and/or interference of the adverse event. Based on the safety profile of tarlatamab and SOC therapy, the study included the following symptoms: shivering or shaking chills, anxiety, constipation, taste changes, vomiting, headache, concentration, rash, palpitations, arm or leg swelling, nausea, dizziness, bruising, fatigue, and decreased appetite, which were deemed relevant for the site of cancer as well as cancer treatment. Responses were typically scored on a 5-point ordinal scale, with values ranging from 0 to 4. Higher scores indicated greater symptom burden.

time frame

Up to approximately 4 years

analysis role

secondary

reporting status

NOT_POSTED

higher is better

0

direction quote

Higher scores indicated greater symptom

population note

Source null

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-small-cell-lung-cancer-hycamtin-146fc378

nct id

NCT05740566

qol key

qol-0017

source section id

NCT05740566-om-0017

source outcome index

17

instrument

FACT

instrument basis

matched 'fact-g' in the study's own wording

scale title

Change From Baseline in Symptom Bother as Measured by Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire

measure definition

FACT-G was a 27-item questionnaire designed to measure four domains of health-related quality of life in cancer patients: physical, social, emotional, and functional well-being. The GP5 of the FACT-G was a single item: "I am bothered by side effects of treatment", rated on a 5-point Likert scale from 0: not at all to 4: very much. Higher scores indicated greater impact of side effects. A negative change from baseline indicated improvement in impact of side effects.

time frame

Up to approximately 4 years

analysis role

secondary

reporting status

NOT_POSTED

higher is better

Source null

direction quote

Source null

population note

Source null

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z